Metered-Dose Inhaler Security System

ABSTRACT

Security features for an electronic metered-dose smart inhaler, mobile app, and cloud-based software system for use with medical prescriptions and clinical trial regimens. The smart inhaler requires several types of user validation and feedback, and enters a locked-out state when required user feedback is not received or when received user feedback raises a suspicion of fraudulent or improper use. While the smart inhaler system is well suited for aerosol medical marijuana products, it may be used to deliver and conduct clinical trials on any type of product suitable for aerosol administration including other types of medication and non-medical products, such as nicotine, herbal products, pain killers, sleep aids, dietary stimulants, dietary suppressants, etc. The security features are not limited to aerosol inhalers, and may be applied more widely to other types of in-home, patient-administered products.

REFERENCE TO RELATED APPLICATION

This application claims priority to commonly owned U.S. patentapplication Ser. No. 16/270,375 (now U.S. Pat. No. ______), which claimspriority to U.S. Provisional Application Ser. No. 62/628,102 filed onFeb. 8, 2018 and 62/644,837 filed on Mar. 19, 2018, all of which areincorporated by reference.

TECHNICAL FIELD

The present invention is directed to security features for an electronicmetered-dose inhaler and related systems suitable for monitored andcontrolled human inhalation of aerosol products without burning orvaporizing the products.

BACKGROUND

Physicians, clinical trial administrators, and product formulators lackeffective security mechanisms for ensuring that patients and clinicaltrial participants taking self-administered medications and otherproducts adhere to medical prescriptions and clinical trial protocols.They also have very limited product delivery choices for ensuring thedelivery of precise amounts of medicine and other products that areself-administered by patients and clinical trial participants.Conventional delivery systems for products under prescription andclinical study, such as medication, nicotine, herbal products, painkillers, sleep aids, dietary stimulants, dietary suppressants, etc.,also lack effective security mechanisms to prevent unauthorized productuse and confirm that only the authorized user has taken an authorizedproduct in accordance with an authorized protocol. This hampers theability of physicians, clinical trial administrators, and productformulators to assess patient absorption rates, product efficacy, sideeffects, and optimize product formulations and dispensing techniques.They also lack effective, secure and authenticated electronic techniquesfor gathering per-dose data and user feedback related to the benefitsand side effects from in-home, self-administrated products. This needapplies generally to many types of products under prescription, clinicaltrial, or experimental testing.

As medical marijuana (“MMJ”) continues to become legalized across theUnited States and worldwide, physicians prescribing MMJ treatmentoptions for select patients will benefit from understanding the MMJproduct options and medicines available by licensed MMJ cultivators andformulators. Conventional technology does not provide an automaticallyupdated database of available MMJ medicines and patient efficacyinformation that physicians can reference to assist in making informeddecisions when selecting MMJ formulations and treatment regimes.Traditionally, doctors refer to the Physician's Desk Reference (“PDR”)for guidance on selecting and prescribing medications. But the currentPDR does not even contain a category for MMJ. A need therefore existsfor new techniques to provide physician guidance to assist inidentifying patient conditions suitable for MMJ treatment andprescribing MMJ products well suited to the specific needs of patientswith various conditions.

At the same time, a wide range of MMJ products are continually beingdeveloped containing precise strains of cannabis and carefully craftedcombinations of cannabinoid extracts formulated and tested to beeffective for specific ailments. For example, specific MMJ formulationsare in various stages of development, clinical testing, approval anddeployment for epilepsy, insomnia, intractable pain, migraine headaches,PTSD, Parkinson's, essential tremor, and other ailments. Typically, eachailment is most responsive to a specific MMJ formulation, and the searchfor specific MMJ formulations to treat a range of ailments is an ongoingindustry focus. While many of these conditions are very serious and indesperate need of effective treatments, the MMJ products underconsideration are generally considered relatively benign as compared tomany other types of medications under development, such aschemotherapies. Less stringent clinical trial and experimental producttesting procedures, such as in-home, patient-administered options, maytherefore be considered appropriate for MMJ formulations. But cannabisis a well-known recreational drug and there are no in-home,patient-administered MMJ administration systems currently available thatprovide adequate safeguards to ensure that only authorized patents takethe cannabis medications according to authorized protocols.

Another major challenge within the MMJ industry is that there are noconsistent and very precise dispensing and delivery methods for MMJproducts that can be recommended with confidence by physicians to theirpatients. Simply instructing patients to smoke a quantity of cannabisflower produces widely varying results among patients. Smoking cannabisis the most unsafe method for consuming the drug due to thecarbonization of plant material during the combustion phase. Themajority of states that allow MMJ use therefore do not permit the saleor medicinal use of plant material (leaves/flowers/buds) for smoking.Most states instead require the MMJ processors to use extractionprocesses that remove the beneficial oils from the plant material toform a liquid concentrate of cannabinoids and terpenes. This oil canthen be used to produce alternate forms of MMJ consumption. One commonmethod of prescribing the oil is in the form of a vape pen, similar toan electronic cigarette. The oil is combined with a carrier agent andthen package in a cylindrical cartridge that contains an internalheating coil. The cartridge is then attached to a battery powered devicewhich heats the coil to a high temperature to vaporize the mixture,allowing the patient to inhale the oil. Again, the heat required tovaporize the oil destroys many of the beneficial cannabinoids in theoil. Other factors that negatively affect the ability to controldispensing through inhalation include inconsistent inhalation depth andduration by the patient (long or short inhale), how long the inhaledproduct is held in the lungs by the patient (2 seconds or 20 seconds).The primary advantage to smoking or vaping MMJ is that “time to onset”is relatively quick and the effects of the MMJ is generally felt by thepatient in only a few minutes. Ingesting edible MMJ products typicallyhas a much longer time to onset, up to an hour, as well as a longerduration of the effect.

Other types of MMJ products include packaging the extracted oils in geltablets, tinctures in glass bottles with eye droppers or in the form ofedible products. The quantity of MMJ product ingested by the patient isvirtually impossible to verify, as is the amount of the prescribedproduct that makes it through the patient's digestive system and intothe bloodstream. Stomach acids destroy and the liver filters out many ofthe beneficial cannabinoids in the medicine. For example, when a patientingests a 10 mg gel tab, after traveling through the digestive tract,only 15% to 30% of the medicine is typically absorbed into thebloodstream. MMJ ingestion again poses challenges for physicians incontrolling accuracy and consistency in the delivery of the medicine.Bioavailability is also heavily impacted when smoking or vaping MMJbecause the amount of cannabinoids that are destroyed or damaged bycombustion or extreme heating is significant. A need therefore existsfor new MMJ product delivery techniques that do not rely on burning orvaporizing the MMJ product at the time of consumption.

SUMMARY

The present invention meets the needs described above through securityfeatures for an electronically controlled metered-dose inhaler (“smartinhaler”) and related systems and methods for delivering, controllingand monitoring aerosol products, such as MMJ medications. The smartinhaler requires several types of user validation and feedback, andenters a locked-out state when required user feedback is not received orwhen received user feedback raises a suspicion of fraudulent or improperuse. While the smart inhaler system is well suited for delivering MMJproducts, it may be used to deliver any type of product suitable foraerosol administration including other types of medication andnon-medical products, such as nicotine, herbal products, pain killers,sleep aids, dietary stimulants, dietary suppressants, and so forth. Thesmart inhaler system provides a robust, network-based system forin-home, patient-administered medications and other products formonitoring disease (or other condition) progression, conducting clinicaltrials, developing new drugs, evaluating experimental drugs, and soforth. Many of system innovations described in this disclosure are notlimited to aerosol inhalers and may be applicable to other types ofelectronically-controlled, network-connected “smart delivery” devices,such smart nebulizers (e.g., vape pens), potable liquid dispensers,intravenous units, and other in-home, patient-administered deliverydevices.

It will be understood that specific embodiments may include a variety offeatures in different combinations, as desired by different users. Thespecific techniques and structures for implementing particularembodiments of the invention and accomplishing the associated advantageswill become apparent from the following detailed description of theembodiments and the appended drawings and claims.

BRIEF DESCRIPTION OF THE FIGURES

The numerous advantages of the smart inhaler may be better understoodwith reference to the accompanying figures in which:

FIG. 1 is block diagram of a smart metered-dose inhaler system.

FIG. 2A is a perspective view of a smart inhaler.

FIG. 2B is a perspective view of the smart inhaler illustrating a pumpunit and a separate cartridge that includes a mouthpiece unit containingan aerosol canister.

FIG. 3A is a perspective view of the cartridge illustrating the aerosolcanister separated from the mouthpiece unit.

FIG. 3B is a perspective view of the cartridge illustrating the aerosolcanister installed in the mouthpiece unit.

FIG. 3C is a perspective view of the smart inhaler illustrating thecartridge installed into the pump unit.

FIG. 3D a cut-away side view of the mouthpiece unit showing anillustrative embodiment of a single-use clasp.

FIG. 3E is a perspective view of the mouthpiece unit showing thesingle-use clasp.

FIG. 4A is a side view of the pump unit illustrating a key for anengagement lock.

FIG. 4B is side sectional view of the cartridge illustrating a toggleabutment engagement lock abutment in a locked position.

FIG. 4C is side sectional view of the cartridge illustrating the toggleabutment engagement lock in an unlocked position.

FIG. 4D is side sectional view of the cartridge illustrating a fixedabutment engagement lock in a locked position.

FIG. 4E is side sectional view of the cartridge illustrating the fixedabutment engagement lock in an unlocked position.

FIG. 5 is a logic flow diagram illustrating a security procedure forlocking and unlocking the smart inhaler.

FIG. 6 is a logic flow diagram illustrating a procedure for notifying auser that the aerosol canister in the smart inhaler needs to bereplaced.

FIG. 7 is a logic flow diagram illustrating a procedure for placing thesmart inhaler into a locked-out state and activating associatednotifications and alarms.

FIG. 8 is a logic flow diagram illustrating a procedure for unlockingthe smart inhaler during a dosing window.

FIG. 9 is a logic flow diagram illustrating a security procedureimplemented by the smart inhaler.

FIG. 10 is a block diagram illustrating information exchange between thesmart inhaler, a mobile smart inhaler app, and a cloud-based system.

FIG. 11 is a logic flow diagram illustrating a procedure for downloadinginformation from the cloud to the mobile app and the smart inhaler.

FIG. 12 is a logic flow diagram illustrating a procedure for uploadinginformation from the smart inhaler to the mobile app and the cloud.

FIG. 13 is a logic flow diagram illustrating a procedure integrating thesmart inhaler with the mobile app and other platforms over the cloud.

FIG. 14 is a conceptual illustration of a user interface displayed bythe mobile app showing a dosing schedule.

FIG. 15 is a conceptual illustration of a first user interface for aquestionnaire displayed by the mobile app for receiving user feedback.

FIG. 16 is a conceptual illustration of a second user interface for thequestionnaire.

FIG. 17 is a conceptual illustration of a user interface displayed bythe mobile app for receiving multi-media and interactive user feedback.

DETAILED DESCRIPTION

Embodiments of the smart inhaler system include an electronicallycontrolled metered-dose inhaler device (referred to as the “inhaler,”“smart inhaler,” “MDI” or “SMDI”) and related systems and methods thatsecurely controls, monitors, and gathers user feedback and auxiliarydevice data, such as blood pressure, heart rate, and blood glucose data,related to inhaler usage. The system provides the gathered data forreview and analysis by monitors, such as formulators of medications (andother inhalant products), prescribing physicians, clinical trialadministrators, artificial intelligence, researchers, developers,facility operators, parents, guardians, authorities, and otherauthorized parties. The smart inhaler is specifically designed toadminister aerosol products without the need to burn, vaporize, combineor otherwise prepare the products, other than by shaking the inhaler, atthe time of inhaler use. The smart inhaler also ensures proper shakingprior to unlocking the inhaler for a dosing event.

The smart inhaler is suitable for administering MMJ protocols but is notlimited to MMJ or other prescribed medications. The smart inhaler can beused to administer any type of inhaler protocol, such as medicalprescriptions, clinical trials, and other protocols related torehabilitation, addiction withdrawal, exercise, diet, safety testing,efficacy testing, judicial supervision, and so forth. The specificexamples described in this disclosure are well suited to administering awide variety of aerosol products in a range of protocols specifyingdosing event quantities and time schedules. For example, the smartinhaler system could be used to administer nicotine, herbal products,anesthesia, and other non-medication type products. The smart inhalersystem also allows medical prescriptions and other protocols to bechanged remotely, typically in response to user feedback received in thecourse for the protocols. While the innovations have widerapplicability, the illustrative embodiments are specifically designedfor administering aerosol cannabis medications without the need to heator vaporize the medication as part of inhalant administration.

The smart inhaler system presents tremendous opportunities for secure,per-dose monitoring of in-home, patient-administered medications andother products for monitoring disease (or other condition) progression,conducting clinical trials, developing new drugs, evaluatingexperimental drugs, and so forth. Many of the system-based andcloud-based innovations described in this disclosure are not limited toan inhaler and the product administering device and, as such, may beapplicable to electronically controlled nebulizers (vape devices),potable liquid dispensers, intravenous units, and other types of productdelivery devices.

The representative embodiment includes multiple security features,including features implemented by an electronically-controlled smartinhaler that reads electronically-readable canister information carriedon the cartridge (i.e., on the canister or on the mouthpiece carryingthe canister), features implemented by an a mobile app running on auser's mobile communication device (e.g., smartphone), and featuresimplemented by a number of network resources referred to collectively asthe “cloud.” The cloud may include a wide range of databases andsystems. The examples illustrated by the specific embodiments includesystems operated by the formulator (e.g., manufacturer of the canistercontents), the provider (e.g., prescribing physician or clinical trialadministrator), dispensaries (including mail order dispensaries) thatissue pump units and cartridges to users, and artificial intelligenceplatforms that analyze smart inhaler and related data from multipleusers to identify medically significant factors and trends for use inefficacy analysis and the development of new protocols and formulations.

The smart inhaler system also integrates a range of auxiliary monitoringdevices used to collect diagnostic data from a user in the course of aprotocol. Representative auxiliary devices include a blood oxygenmonitor, heart rate activity monitor, respiration monitor, bloodpressure monitor, body temperature thermometer, blood glucose monitor,and so forth. The mobile app gathers and correlates the smart inhalerdata with the measurement data from the auxiliary devices, for exampleby synchronizing, scaling and organizing the data for combined displayon a common chart or time scale. The smart inhaler data set may beaugmented with other diagnostic data obtained separately, such as MRI,CAT, X-ray, EKG, EEG, genome sequencing, medical history, family medicalhistory, etc. Additional analysis conducted by the mobile app or cloudsystems help to reveal the effect of the products delivered throughinhaler operation on the user, which is typically reflected by themeasurement data obtained by the auxiliary monitoring devices.

The smart inhaler system includes a number of safeguards to ensure thatthe inhaler is only used by the authorized user in an authorized manner.This makes the smart inhaler system suitable for use in manyapplications where security is an important factor. For example, a smartinhaler may be used to ensure that a controlled substance orprescription medication is only administered to the proper patient inaccordance with a proper prescription. This address the several problemswith conventional medication delivery systems, such as another personsurreptitiously taking the patient's medication, the patient selling orgiving the medication to someone else, the patient not taking themedication in accordance with the prescription, use of expiredprescriptions, effectively administering product recalls, andeffectively administering clinical trials. The inhaler pump unit may beissued separately (e.g., when a prescription, clinical trial or otherprotocol is initiated), while the cartridges will typically be issuedseparately and more frequently (e.g., each time a protocol cartridge isrefilled). The inhaler pump unit is therefore designed to be used formany canisters, while each mouthpiece units is designed to be used witha single canister as a one-time use disposable cartridge. If desired,the same inhaler can be configured, for example through the use ofpasswords, MMJ Registration Card numbers, and bio-identifiers togetherwith reading of cartridge (canister) information and prescriptionverification, to handle multiple prescriptions for individual ormultiple persons. Bluetooth® pairing, along with cartridge andprescription verification, allows the same inhaler pump unit to beconfigured to communicate with multiple apps running on different mobiledevices registered to different users. For example, a single pump unitcould be used to administer products to multiple patients or clinicaltrial subjects who travel to the same location for inhaler use.

The smart inhaler system includes several different types of safeguards.Particular embodiments may include one or more of these safeguardfeatures, and each inhaler need not include all or any particularcombination of these features. A specific smart inhaler is typicallyregistered to work only with a specific mobile device, as controlled bya mobile app running on the mobile device. A user's smart inhaler pairswith the user's mobile communication device, typically through aBluetooth link, to verify that the inhaler is registered to the user,and that the canister corresponds to a valid prescription written forthe user. Although the user's smart inhaler may operate according to averified prescription without connecting to the user's mobile device atthe time of product administration, it must be connected at some pointprior to initial product administration to confirm that the canister inthe user's inhaler corresponds to the user's prescription. The mobileapp keeps track of the number of doses taken and the number remaining inthe canister. The inhaler and the mobile app provide a variety ofnotifications indicating that a dosing window is open, the canister isnearing empty, the canister is empty, and when the canister is placedinto a locked-out state for a number of different reasons. For example,the inhaler may be locked-out for use with a particular cartridgebecause it is not loaded with a verified cartridge, the cartridge hasbeen recalled or expired, there are no more doses remaining in thecanister, or when unauthorized use has been detected or been attempted.In a particular embodiment intended for a child or elderly person'sinhaler, voice notifications may be played in a voice familiar to theuser. Notifications or alarms may also be sent by voice message, textmessage, email or other techniques to a communication device associatedwith an authorized third party, such as a parent, guardian, physician orcare taker. In another embodiment intended for clinical testing,notifications or alarms may be automatically sent to the administratorof the clinical trial.

In addition, there three types of physical locks available, a single-useclasp in the mouthpiece, a dispensing button lock, and an engagementlock. The single-use clasp allows a canister to be inserted into themouthpiece unit one time, and then breaks away to disable the mouthpieceif the canister is removed from the mouthpiece. This effectivelyconfigures the mouthpiece as a disposable unit restricted to workingwith a single canister. The dispensing button lock includes a movableabutment controlled by the microprocessor in the pump unit that onlyallows the dispensing button to be depressed to dispense product fromthe canister in accordance with a valid and verified protocol. Theengagement lock includes an abutment in the mouthpiece that preventsproduct from being dispensed from the canister when the mouthpiece isnot installed in the pump unit. This prevents unauthorized persons fromcircumventing the dispensing button lock by manually depressing thecanister into the mouthpiece when the mouthpiece is not installed in thepump unit.

The cartridge, consisting of a canister installed in a mouthpiece unit,carries an electronically readable label or chip with information aboutthe product in the canister, such as a medication description. The pumpunit will not work with a cartridge until the cartridge has beenvalidated with a prescription (or other protocol) for use by the user.Cartridge verification requires the pump unit to read canisterinformation stored by a cartridge memory carried by the cartridge. Thepump unit must also become paired with and interact with the mobile apprunning on a mobile device that is registered for use with that specificpump unit (or canister in a multi-user embodiment). This requiresmatching the cartridge with a valid prescription (or other protocol)written for the authorized user of the inhaler. While the pump unitreads the cartridge information from the cartridge memory, the user'sprescription (or other protocol) is typically obtained from anotherlocation, such as the cloud via the mobile app running on the user'smobile device.

An authorized user may also be required to enter pre-dose identificationinformation, such as a password, MMJ Registration Card number, orbio-identifier (e.g., fingerprint, retina scan, etc.), to activate theinhaler. The user may also be required to enter post-dose feedbackthrough the mobile app, which may include providing a written account,picture, photo, chat or other multi-media or interactive feedback. Thepost-dose feedback may be required immediately after taking a dose andat one or more other times following a dose. The post-dose feedback maybe used to detect suspected fraudulent or improper use of the inhaler,which causes the inhaler to enter a locked-out state until the suspectedfraud or improper use has been resolved. Feedback received from themobile app can be used for a number of other purposes including doseconfirmation, prescription modification, and analyses of medicationefficacy, side effects, time to onset, and so forth. Feedback frommultiple users may be used to create a multi-user, multi-productdatabase for further analysis including analysis by artificialintelligence and other researchers.

Illustrative embodiments of the smart inhaler and related systems andmethods are described below with reference to the appended figures. FIG.1 is conceptual block diagram of a smart metered-dose inhaler system 10.In the illustrative embodiments, the user's mobile app 12 (denoted asthe “Smart MDI Inhaler Device App”), the mobile app 16 (denoted as the“Green Care App”) used by the physician or clinical trial administrator15 a, a similar app used by the formulator 18, an artificialintelligence platform 19 a, and platforms associated with otherauthorized parties 19 b (e.g., researchers, developers, parents,guardians, care takers, judicial supervisors, parole officers, addictionrecovery monitors, etc.). These online systems communicate with eachother through a cloud-based network and database 17 (also referred to asthe “cloud” for shorthand, denoted as the “Green Care Software/Network”)to exchange information related to use of the smart inhaler 11. It willbe understood that the actions performed by the patient are generallyperformed through user interaction with the mobile app 12 or in somecases the smart inhaler 11 (unless otherwise noted or connoted by thecontext), and that actions performed by the provider are generallyperformed through interaction with the online provider system 15 a viathe mobile app 16 (unless otherwise noted or connoted by the context).Similarly, actions performed by the patient on the provider system 15 aare performed through network communications between the mobile app 12and the mobile app 16 over the cloud 17. In the same vein, actionsperformed by the formulator are generally performed through an onlineformulator platform 18 over the cloud 17 (unless otherwise noted orconnoted by the context), and so forth.

A central feature of the system 10 is an electronically-controlled,hand-held, smart metered-dose inhaler 11, which includes a pump unit 11a and a removable cartridge 11 b that includes a mouthpiece unitcarrying a canister (see FIGS. 2A-2B) filled with an aerosol product ofinterest (e.g., MMJ formulation) that is properly pressurized (e.g., toabout 80 psi) with a medically safe inhalant (e.g., HFA-134a). The pumpunit 11 a includes an onboard microprocessor 11 c, memory 11 d, andaccelerometer 11 e. The accelerometer is used to detect that the smartinhaler has been adequately shaken as a condition for unlocking theinhaler to administer a dose. The smart inhaler 11 (or the cartridge ina multi-cartridge or multi-user embodiment) is registered for use withthe mobile app 12 running on a mobile device associated with anauthorized user. The mobile app 12 controls the smart inhaler 11 andalso integrates information associated with operation of the inhalerwith other information, such as medically relevant measurements obtainedfrom ancillary devices 13. In this particular embodiment, the exampleancillary devices 13 are represented by a blood oxygen monitor, a heartrate activity tracker, and a blood pressure monitor.

The mobile app 12 communicates over a suitable network (e.g., mobiletelephone, private data network, Internet, intranet, ethernet, etc.)with the provider system 15 a, which issues a prescription 15 b for theuser, which the user typically picks up or receives in the mail from adispensary 15 c. For example, the prescription 15 b may be issued in theform a cartridge 11 b including an aerosol medication canister heldwithin a mouthpiece unit that is inserted into the pump unit 11 a of thesmart inhaler 11. This allows the same pump unit 11 b to be used withmany different cartridges including refill cartridges. The providersystem 15 a may obtain additional clinical tests 14 related to the user,such as blood tests, lab tests, and so forth. The provider system 15 aalso interacts with other elements of the system 10. For example, theprovider system 15 a typically orders medication cartridges withspecific formulations from the formulator 18, which delivers prescribedcartridges to the dispensary 15 c for delivery to the patient.

Ultimately, many smart inhalers, physicians, clinical trialadministrators, formulators, Al platforms, researchers, and developerswill be interconnected by the cloud 17 allowing a large body of clinicaldata to the gathered regarding inhaler use, user feedback, auxiliarydevice data, clinical tests, and other relevant data for use inprescribing medications and conducting research and development. Thiswill include analyses conducted by artificial intelligence as wells ashuman R&D teams at universities, foundations, corporations, and soforth. The system 10 thus represents an important advancement in thefield of MMJ because this type of data is currently lacking, while awide range of MMJ products are currently being developed to treat a widerange of conditions. The system 10 also represents an important and moregeneral advancement in security, monitoring and administration ofprescriptions, disease (and other condition) progression, clinicaltrials, and experimental drug testing through distributed used ofin-home, patient-administrated delivery devices.

To further advance the research and development process, the cloud 17connects the elements of the system 10 with an artificial intelligence(“AI”) system 19, which includes one or more platform and relatedsoftware, which may include multiple Al platforms at various researchuniversities, foundations and companies. Generally described, the Alsystem 19 receives patient medical data from the various systemsinterconnected by the cloud 17, applies predictive modeling, andprovides enhanced data and predictive modeling results back to othercloud elements. This information can then be used to develop new MMJformulations and protocols. The patient medical data supplied to the Alsystem 19 typically includes, but is not be limited to, device status,medication usage, dispensing habits, formulation efficacy, and patientfeedback gathered on various devices and network servers. The Al systemsoftware automatically sorts, parses and analyzes all data and places itinto unique categories. These categories may be created based on avariety of inputs, such as but not limited to, current medicaldiagnosis, physiological characteristics (age, weight, sex, race, healthstatus, etc.), family medical history (mother, father, grandparents,etc.), DNA analysis (ancestry, genealogy, genetic predisposition todiseases/medical conditions), etc. The Al software analyzes all of thesefactors along with any other available data that could possibly impactthe outcomes of treatment for each individual and then incorporatepredictive modeling for improving efficacy of medications and treatmentplans based on combinations of the patient inputs.

For example, when the Al software has processed and analyzed theavailable characteristics data from 200 individual patients sufferingfrom multiple sclerosis (MS) in combination with their prescribedtreatment plans, treatment adherence, prescribed medicineformulation(s), efficacy results and personal feedback and other input,the Al can then begin to model this data to predict how individuals willlikely react to specific treatment plans for MS. Expanding on thisexample, when the Al has identified a treatment plan (e.g., specificformulation(s), dosing amounts, dosing frequency, duration of treatment,etc.) with a target success rate (e.g., 72%) for a specific group ofpatients suffering with MS and with very similar characteristics, the Alcan generate an optimized medical cannabis treatment plan for physiciansto administer and prescribe to new MS patients. This guidance inprescribing a treatment plan, with a high success rate, will eliminaterelying on physicians to effectively guess at what may or may not beeffective for an MS patient. With regards to the portion of MS patientsthat did not benefit from treatment plan under evaluation (i.e., theother the 28% in the example with a 72% success rate), the Al can makepredictions and suggest to the formulator how a specific formulation canbe adjusted and optimized for higher efficacy for these remainingpatients. The Al may also provide suggestions to a physician on whataspects of a potential treatment plan may provide more benefits to thesepatients. As more efficacy data for MS patients is collected andanalyzed, the Al predictive modeling for effective formulations andsuccessful treatments plans for individual patients will become moreaccurate.

FIG. 2A shows a representative embodiment of the smart inhaler 11, whileFIG. 2B shows the smart inhaler with the pump unit 11 a separated fromthe cartridge 11 b. The pump unit 11 a includes a pump actuator 23(e.g., dispensing button), the microprocessor 11 c, the memory 11 d, andthe accelerometer 11 e described with reference to FIG. 1, which arepowered by an onboard rechargeable battery 24. The battery 24 alsopowers an onboard wireless radio 21 and GPS unit 22. The wireless radio21 is operative for pairing and communicating with the mobile app 12running on the user's mobile device, and the GPS unit 22 allows thelocation of the inhaler 11 to be tracked by the mobile app 12. Thewireless radio 21 and the GPS unit 22 also allow the location of theinhaler 11 to be tracked remotely by the provider system 15 a (typicallyby the provider mobile app 16), the formulator system 18, the Alplatform 19 a and the other authorized party systems 19 b as provided byan authorized protocol. This allows one or more of these systems toremotely monitor, enable and disable the smart inhaler 11, for exampleover the cloud 17 or another suitable network (e.g., mobile telephone,wireless data, 5G, Internet of things (IOT), etc.). The remote systemscan also use the location of the smart inhaler 11, along with thelocations of many other similarly equipped smart inhalers, as ademographic parameter for controlled substance monitoring, supervisoryuser monitoring, artificial intelligence, research, development, andother purposes in accordance with authorized protocols. The smartinhaler 11 may also carry other onboard devices powered by the battery24 for user identification, security protocols, notifications, alarmsand communications, such as a camera, speaker, microphone, vibrator,data encryption, personal health record storage, bio-identification(e.g., fingerprint reader, retina scanner, voice recognition, etc.) andother desired functionality.

The cartridge 11 b includes a canister 25 that is permanently attachedto a mouthpiece unit 26 by a single-use clasp 27. The single-use clasp27 engages the canister 25 when the canister is initially installed intothe mouthpiece unit 26 to prevent the canister from being removed fromthe mouthpiece unit without breaking the clasp, which disables themouthpiece from operably receiving another canister. The single-useclasp 27 is a safety measure that effectively turns the mouth-piece intoa disposable single-canister device. The cartridge 11 b also includes acartridge memory 28, such as a barcode, QR code, RFID tag, or NFC chip,that contains canister information including a description of theproduct contained in the canister 25. The single-use clasp 27 restrictsthe mouthpiece unit 26 to working with a single canister 25, whichallows the cartridge memory 28 to be carried by the canister 25 or themouthpiece unit 26, as desired. Thus, the cartridge memory 28 istypically encoded when the canister 25 is installed into the mouthpieceunit 26. The pump unit 11 a includes a cartridge reader 29 powered bythe onboard battery 24 that reads the cartridge memory 28 when thecartridge 11 b is installed in the pump unit. The medication descriptionmay be directly stored by the cartridge memory 28, or the cartridgememory may store a code that the microprocessor 11 c uses to look up(index) an associated medication description stored in the memory 11 d(i.e., the memory may store an onboard medication index updated from thecloud 17 from time to time). Alternatively or additionally, the mobileapp 12 may use the code to look up (index) an associated medicationdescription stored in the cloud 17, for example in an online medicationdatabase associated with the formulator 18 or the provider 15 a.

In particular embodiments, for example, the cartridge memory 28 may be abarcode, RFID tag, or NFC chip and the cartridge reader 29 may be anoptical barcode reader, RFID reader, or NFC reader. In the barcode andRFID embodiments, the cartridge reader 29 is typically turned onmomentary upon a cartridge being installed to allow the pump unit toread the cartridge memory 28. In an NFC embodiment, the NFC antenna inthe cartridge is typically turned on momentary upon a cartridge beinginstalled to allow the NFC reader in the pump unit to read the NFC tag.Upon successfully reading the tag data, the NFC antenna automaticallyturns off to conserve battery power until a new cartridge installationevent.

The user pairs the microprocessor inside the pump unit 11 a with themobile device running the mobile app 12 (e.g., via Bluetooth link) toactivate and control the smart inhaler 11. As a security measure, themobile app 12 checks the registration information of the mobile deviceagainst the registration information of the smart inhaler 11 (or thespecific canister 25 in a multi-user embodiment) to ensure that theinhaler is going to be used by an authorized user. The medication withinthe canister 25 is identified by the canister information stored by thecartridge memory 28. When the cartridge 11 b is inserted into the pumpunit 11 a, the cartridge memory reader 29 in the pump unit reads thecanister information from the cartridge memory 28, which is uploaded tothe mobile app 12. The mobile app 12 also downloads the user'sprescription from the provider system 15 a. As another safeguard, thepump unit 11 a keeps the pump actuator 23 locked (e.g., an abutmentblocks the dispensing button) unless the mobile app 12 verifies that theproduct in the canister 25 corresponds to a valid prescription issued tothe user verified through the provider system 15 a. Upon verification ofthe user registered to the inhaler 11, a valid prescription issued tothe same user, and determination that a dosing window is open inaccordance with the prescription, the pump unit 11 a unlocks the pumpactuator 23 for a dosing event, for example by moving an abutment tounblock the pump actuator.

FIG. 3A shows the cartridge 11 b with the aerosol canister 25 separatedfrom the mouthpiece unit 26, while FIG. 3B shows the canister installedinto the mouthpiece unit and FIG. 3C shows the smart inhaler 11 fromabove. FIG. 3D and FIG. 3E show the mouthpiece unit 26 including anillustrative embodiment of the single-use clasp 27. The canister 25includes a valve stem 31 that dispenses a small quantity of the contentsof the canister when the valve stem is pushed into the canister. Whendepressed, the pump actuator 23 pushes the canister 25 downward into themouthpiece unit 26, which pushes the valve stem 31 into the canister 25to release a small quantity of the contents of the canister through themouthpiece unit. The microprocessor 11 c controls the pump unit 11 a tomove an abutment 35 to block and unblock the pump actuator 23 to lockand unlock the inhaler 11. The pump action caused by depressing the pumpactuator 23 may be controlled by an internal motor or by the usermanually pressing down on the dispensing button. The mouthpiece unit 26includes a reusable clip 32 for removably attaching the cartridge 11 bto the pump unit 11 a with the pump actuator 23 positioned to push thecanister 25 into the mouthpiece unit 26 to dispense the contents of thecanister through the mouthpiece. The user pinches a grip surface 33adjacent to the clip 32 to remove the cartridge 11 b from the pump unit11 a. The cartridge memory 28 carried by the cartridge 11 b ispositioned to be readable by the cartridge memory reader 29 carried bythe pump unit 11 a when the reusable clip 32 attaches the cartridge tothe pump unit in an operable configuration in which the pump actuator 23is positioned to reciprocate the canister 25 within the mouthpiece unit26 to release the contents of the canister through the mouthpiece unit.The single-use clasp 27 includes a pair of flanges that are angleddownward in the direction of insertion of the canister 25. The flangesbend slightly without breaking to allow the canister 25 to be inserteddownward into the mouthpiece unit 26. The flanges break away, however,if the canister 25 is forced upward out of the mouthpiece unit 26.

The pump unit 11 a also includes an LED indicator 34 powered by theonboard battery 24 that indicates the status of the pump unit. Forexample, the LED indicator 34 may be off when the smart inhaler 11 islocked between dosing events, may illuminate or flash green to indicatethat the inhaler is unlocked and ready for a dosing event, and mayilluminate or flash red when the smart inhaler is in a locked-out state.For example, the LED may illuminate or flash red to when the inhaler islocked-out due to a pairing failure caused by a mismatch between theinhaler (or canister) credentials and the user's credentials stored bythe user's mobile unit. The inhaler may also lock-out due to a mismatchbetween the medication in the canister, as reflected by the canistermemory, and the user's prescription or recall or expiration of theproduct in the canister. As additional examples, the inhaler maylock-out because the user has not entered required feedback for a priordose, because fraudulent use or attempted misuse of the inhaler has beendetected, due to a canister recall or expiration, or a change inprescription removing the user's authorization to take the medication inthe canister. The LED may flash in different patterns to signify thesedifferent lock-out reasons. The LED indicator may also be augmented byaudible alarms, a voice notification, or a vibration to indicate theinhaler status. The pump unit status may be accompanied by notificationsdisplayed or played by the user's mobile device under the control of themobile app 12. Voice notification by the pump unit or the mobile app maybe particularly useful for children, elderly, and ill users who may bemore likely to understand or comply with voice notifications in afamiliar voice, such as notifications recorded in the voice of a parent,guardian, other family member, care taker, or physician.

FIG. 4A shows the pump unit 11 a while FIGS. 4B-4E show cut-away viewsof the cartridge 11 b illustrating an engagement lock that prevents thecanister 25 from being manually depressed into the mouthpiece unit 26 todispense the contents of the canister when the cartridge is notinstalled in the pump unit. As shown in FIG. 4A, the pump unit 11 aincludes an engagement lock key 41 that is inserted into the cartridge11 b when the cartridge is installed in the pump unit. As a firstexample, FIGS. 4B and 4C illustrate a toggle engagement lock. As shownin FIG. 4B, a toggle abutment 42 a blocks the canister 25 from beingpushed into the mouthpiece unit 26 when the key 41 is not inserted intothe cartridge 11 b because the cartridge is not properly installed intothe pump unit. As shown in FIG. 4C, when the cartridge 11 b is properlyinstalled into the pump unit 11 a, the key 41 releases the toggleabutment 42 a to allow the canister 25 to be pushed into the mouthpieceunit 26. A spring 43 biases the cartridge 25 in a retraction directionso that the pump actuator can reciprocate the cartridge between theretraction direction (upward in figures) and an opposing insertiondirection (downward in figures) to release a portion of the contents ofthe canister 25 each time the canister is reciprocated to dispense thecontents of the cartridge through the mouthpiece unit 26. When the key41 releases the toggle abutment 42 a, a return spring 44 forces thetoggle abutment to reengage the canister 25 to lock the cartridge.

As another example, FIGS. 4C and 4D illustrate a fixed abutmentengagement lock. As shown in FIG. 4C, a fixed abutment 42 b blocks thecanister 25 from being pushed into the mouthpiece unit 26 when the key41 is not properly inserted into the cartridge 11 b. As shown in FIG.4D, when the cartridge 11 b is properly installed into the pump unit 11a, the key 41 pushes the canister 25 off the fixed abutment 42 b toallow the canister to be pushed into the mouthpiece unit 26. The spring43 biases the cartridge 25 upward so that the pump actuator canreciprocate the cartridge up and down to dispense the contents of thecartridge through the mouthpiece unit 26. When the key 41 is removed,the spring 43 forces the cartridge 25 to reengage the fixed abutment 42b to lock the canister. Other types of keys and abutments may beemployed. For example, security may be enhanced through the use of moresophisticated keys, tumbler locks, magnetic locks, electronic locks, andso forth. As additional examples, the key could include an eccentricplate, multiple prongs, or movement in two or three dimensions making itmore difficult for an unauthorized user to bypass or tamper with theengagement lock.

FIG. 5 is a logic flow diagram illustrating a security procedure 50 forlocking and unlocking the smart inhaler. In step 51, the pump unitdetects engagement of a cartridge, which includes a mouthpiece unitcarrying a canister. The pump unit typically logs engagement anddisengagement events and has the capability to maintain dose counts formultiple cartridges, which allows the same pump unit to be used todispense multiple prescriptions for the same user. In addition, in amulti-user embodiment, the same pump unit may be use to dispense one ormore prescriptions for multiple users. Step 51 is followed by step 52,in which the pump unit reads the cartridge memory containing securityinformation including a description of the medication (or other product)in the canister. Alternatively, the cartridge memory may include a codethat the pump unit or the user's smart inhaler or mobile app uses tolook up the medication description. Step 52 is followed by step 53, inwhich the smart inhaler mobile app pairs with the pump unit and accessdata associating the product in the canister with an authorized user ofthe pump and a dosing protocol authorized for the user, such as amedical prescription or clinical trial regimen. If the product in thecanister is validated for an authorized user, step 53 is followed bystep 54, in which the pump unit loads the dosing protocol. The pump unithas sufficient onboard microprocessor, memory, and battery resources tostore and administer the dosing protocol. The user's smart inhalermobile app initially downloads the dosing protocol from a cloud-basedsystem associated with the user's physician or clinical trialadministrator. Once the smart inhaler mobile app verifies the dosingprotocol, it is downloaded to the pump unit so that the pump unit canadminister the protocol even when connectivity is not available betweenthe pump and the user's smart inhaler mobile app.

Step 54 is followed by step 55, in which the pump unit determines that adosing window is open in accordance with the verified dosing protocol.This typically includes unblocking the pump actuator for a designatednumber of puffs (e.g., pushes of the dispensing button) and activatingnotifications on the pump unit and the user's mobile device. The user'spump unit stores its own copy of the dosing protocol so that the pumpunit can administer the protocol even when connectivity is not availablebetween the pump and the mobile app. Step 55 is followed by step 56, inwhich the mobile app receives and validates user identificationinformation, such as a password, MMJ Registration Card number,fingerprint, retina scan, photo, face scan, voice command, or other useridentification. Step 56 is followed by step 57, in which the smart unitmobile app causes the pump unit to unlock for the dosing event, forexample by removing an abutment that prevents the dispensing button frombeing depressed. Step 57 is followed by step 58, in which the pump unitdetermines that the dose has been administered or the dosing window hasexpired.

If connectivity exists between the pump unit and the smart inhalermobile app, the pump unit uploads this information to the smart mobileunit in real-time time. Otherwise the pump unit uploads the informationwhen connectivity is reestablished. Similarly, if connectivity existsbetween the smart inhaler mobile app and the cloud, the mobile appuploads this information in real-time to the cloud (e.g., with theonline system operated by the user's physician or clinical trialadministrator). Otherwise the mobile app uploads the information whenconnectivity is reestablished. Step 58 is followed by step 59, in whichthe pump unit locks the inhaler, for example by moving the abutment toprevent the dispensing button from being depressed. Following step 59,the routine 50 returns to step 55, in which the pump unit and mobile appwait for another dosing event. When another cartridge engagement isdetected, routine 50 goes back to step 51 (cartridge engagementdetected) and continues from there.

FIG. 6 is a logic flow diagram illustrating a procedure 60 for notifyinga user that the aerosol canister in the smart inhaler needs to bereplaced. In step 61, the user's mobile app determines that the canisteris almost empty. The mobile app may make this determination directly, orit may be made by the smart inhaler and uploaded to the user's mobileapp. The determination may be based on a volume threshold (e.g., only 5does left) or a minimum days remaining per the protocol (e.g., only 5day left on protocol). Step 61 is followed by step 62, in which theuser's mobile app sends a refill notification to one or more of theuser's physician, clinical trial administrator, dispensary or formulatoras appropriate to effect the refill. Step 62 is followed by step 63, inwhich the smart inhaler activates an internal alarm protocol, whichincludes one or more notifications on the pump unit, such as flashingLED, audible notification, vibration, etc. Step 63 is followed by step64, in which the mobile app also activates an external alarm protocolincluding one or more notifications on the user's mobile phone (e.g.,pop-up notification, status bar notification, calendar notification,etc.). Step 64 is followed by step 65, in which the smart inhaler or themobile app determines that the canister is empty, typically bydetermining that no doses remain in the dosing protocol. Step 65 isfollowed by step 66, in which the smart inhaler activates an internalalarm protocol, and the mobile app activates an external alarm protocol,to notify the user that the canister is empty.

FIG. 7 is a logic flow diagram illustrating a procedure 70 for placingthe smart inhaler into a locked-out state and activating associatednotifications and alarms. In step 71, the mobile app receives a stop-usenotification for a selected dosing protocol. For example, stop-usenotification may be received from the online system associated with theprescribing physician, clinical trial administrator, or the formulatorof the product. The stop-use notification may be related to a productrecall, expiration, prescription termination, or clinical trialtermination. The mobile app may also receive and implement other typesof notices over the cloud, such as a start-use notice, single-usenotice, temporary protocol notice, change protocol notice, and so forth.The mobile app cloud connection thus provides a way to remotely controlprotocols and operation of the smart inhaler based on physiciandecisions, formulator decisions, health measurements received fromancillary devices, user feedback, lab test, clinical analysis, and soforth. To aid in these decisions, the mobile app may provide for agreater level of user feedback through multi-media and interactivefeedback over the cloud, such as text chat, video chat, recordedfeedback, email and other multi-media and interactive techniques togenerate a richer data set to monitor side effects and ensure that theuser is experiencing the desired result. Ancillary device measurementsand user feedback, including multi-media and interactive feedback, canalso be used as a safeguard to ensure that the only the authorized useris taking the product in accordance with the authorized protocol.

Step 71 is followed by step 72, in which the smart inhaler is locked-outfor the selected dosing protocol, for example by blocking or disablingthe dispensing button on the pump unit. In multi-protocol and multi-userembodiments, the smart inhaler can be locked-out on a per-cartridge andon a per-user basis. Step 72 is followed by step 73, in which the mobileapp notifies cloud components, as appropriate, of the lock-out status.For example, the prescribing physician or clinical trial administratormay be notified of lock-outs ordered by a product formulator, and theproduct formulator may be notified of the successful lock-out for eachspecific canister subject to a product recall or expiration. Step 73 isfollowed by step 74, in which the pump unit activates an internal alarmprotocol, and step 74 is followed by step 75 in which the mobile appactivates an external alarm protocol, to notify the user of the lock-outstatus.

FIG. 8 is a logic flow diagram 80 illustrating a procedure for unlockingthe smart inhaler for a dosing window. In step 81, the smart inhalerdetermines that a dosing window is open in accordance with an authorizeddosing schedule and previous dose count. Opening of the dosing window istypically accompanied by internal and external notification protocols.Step 81 is followed by step 82, in which the smart inhaler receives andvalidates user identification information, such as a password, MMJRegistration Card number or bio-identifier (e.g. fingerprint, retinascan, photo, face scan, voice command). While the user identificationinformation is typically received through the mobile app, the smartinhaler may be configured to receive certain types of useridentification information (e.g., voice command) so that the smartinhaler can be activated for a dosing event even when connectivity doesnot exist between the mobile app and the smart inhaler.

Step 82 is followed by step 83, in which the smart inhaler determineswhether the inhaler has been properly shaken. More specifically, theonboard accelerometer provides an acceleration signal to themicroprocessor, which may awake from a sleep status and read a shakeprotocol from the on board memory. The shake protocol may be part of thecartridge information read from the memory, which is specific to theproduct in the canister. The shake protocol may also be downloaded fromthe cloud systems associates with the formulator the provider. As aresult, the smart inhaler does not active for a dosing event until theinhaler has been properly shaken, which may be indicated by a change inthe illumination or flashing state of the LED indicator or othersuitable notification (e.g., beeping or voice notification “canister isadequately shaken”). Step 83 is followed by step 84, in which the smartinhaler is unlocked for the dosing event, which may be accompanied byits own internal and external notifications.

FIG. 9 is a logic flow diagram illustrating a security procedure 90implemented by the smart inhaler system. In step 91, the smart inhalerreceives pre-dose authorization from the user, which may be requiredwhen the inhaler is in a locked-out state and when the inhaler is not ina locked-out state. A variety of pre-dose authorization information maybe required based on the desired level of security. For example, thepre-dose authorization information may include a password, MMJRegistration Card number, voice command, touch-screen gesture, and soforth. For additional security, the pre-dose authorization informationmay include a bio-identifier, such as a fingerprint, retina scan, photoor scan of the user's face, signature, voice recognition, or the like. Alower level of pre-dose authorization information may be required everytime the smart inhaler is used, while a higher level may be required ona less frequent basis, such as weekly. A registered user's credentialsacquired at the time of pre-dose authorization, such verified sources ofidentification and a photo of the user's face, may be compared againstthe user's verified credentials stored locally and/or in the cloud(e.g., Federated ID identity management). Although the smart inhalerusually receives the pre-dose authorization through the mobile app,there may be instances where the pre-dose authorization is receiveddirectly by the smart inhaler, for example when there is no connectivitybetween the user's smart inhaler and the user's mobile app. In addition,some embodiments may be configured to routinely receive the pre-doseauthorization through the smart inhaler itself. For example, the smartinhaler may receive the pre-dose authorization through a photo of theuser's face or voice command, which may involve voice recognition. In amulti-user embodiment, the pre-dose authorization may be required for auser registered to use the specific cartridge installed in the smartinhaler.

In general, pre-dose and post-dose verification and feedbackrequirements may be established on a per-cartridge basis. Although theverification procedures may be applied by the mobile app or the smartinhaler, or a combination, mobile app verification for an illustrativesubject protocol is described below. Step 91 is followed by step 92, inwhich the mobile app determines whether the pre-dose authorizationinformation is properly validated. If the pre-dose authorizationinformation is not validated, the “no” branch is followed from step 92to step 98, in which the smart inhaler is placed into a locked-out statefor the subject protocol. If the pre-dose authorization information isvalidated, the “yes” branch is followed from step 92 to step 93, inwhich the inhaler is unlocked for the dosing event. After the dose hasbeen administered, step 93 is followed by step 94, in which the mobileapp should receive post-dose feedback. While required post-dose feedbackis typically maintained by the mobile app 12 in accordance with settingsinformation, the provider 15 a or the formulator 18 may also establishpost-dose feedback requirements or request specific post-dose feedbackon a case-by-case basis. This typically involves a post-dosenotification send from the provider 15 a or the formulator 18 to themobile app 12. User verification is typically required before the usercan enter the post-dose feedback. In addition, multiple types ofpost-dose feedback may be required at one or more different times, suchas dose confirmation immediately following the dosing event and feedbackabout how the user is feeling at a later time. For example, the user maybe required to enter post-dose feedback in the morning to explain howwell the user slept, how well the dose worked, how much pain the userexperienced, other discomfort, and side effects the user may haveexperienced. The smart inhaler may remain locked until the correct typeof post-dose feedback has been received. The post-dose feedback cantherefore be used to monitor product efficacy, patient condition, andside effects on a per-dose basis, which can be very valuable for dosemodification, monitoring disease (or other condition) progression, andclinical trial administration. Missing post-dose feedback may be used todetect fraudulent or other improper use of the inhaler. Post-dosefeedback received, such as textual or photo feedback, can also beanalyzed by the mobile app or cloud-based systems to detect fraudulentor other improper use of the inhaler. The smart inhaler system thusprovides innovative opportunities for secure, per-dose monitoring ofin-home, patient-administered medications (or other products) formonitoring disease (or other condition) progression, conducting clinicaltrials, developing new drugs, evaluating experimental drugs, and soforth.

Step 94 is followed by step 95, in which the mobile app determineswhether the required post-dose feedback has been received. If therequired post-dose feedback not has been received, the “no” branch isfollowed from step 95 to step 98, in which the smart inhaler is placedinto a locked-out state for the subject protocol. If the requiredpost-dose feedback has been received, the “yes” branch is followed fromstep 95 to step 96, in which the mobile app analyzes the post-dosefeedback for fraud detection. This may include downloading informationfrom one or more cloud platforms or uploading the post-dose feedback toone or more cloud platforms that conduct or participate in the analysis.Step 96 is followed by step 97, in which the mobile app determineswhether fraudulent or other improper use of the smart inhaler has beendetected. If fraudulent or other improper use of the smart inhaler hasnot been detected, the inhaler remains in a not-locked-out state for theselected protocol and the “no” branch is followed from step 97 back tostep 91, in which the inhaler waits for another dosing event. Iffraudulent or other improper use of the smart inhaler has been detected,the “yes” branch is followed from step 97 to step 98, in which the smartinhaler is placed into a locked-out state for the subject protocol. Step97 is followed by step 98, in which the smart inhaler initiates anapplicable internal alarm protocol and the mobile app initiates anapplicable external alarm protocol for the locked-out condition.

FIG. 10 is a block diagram illustrating information exchange 100 betweensmart metered-dose inhaler 106, the mobile app 104 running on the user'smobile device, and the cloud 102. FIG. 11 is a logic flow diagramillustrating a procedure 200 for downloading information from the cloud102 to the mobile device app 104, and from the app to the inhaler 106.FIG. 12 is a logic flow diagram illustrating a procedure 300 foruploading information from the inhaler 106 to the app 104, and from theapp to the cloud 102. The description of FIGS. 11 and 12, below, alsorefers to the components shown on FIG. 10, which illustrates oneparticular example information exchange 100 between the cloud 102, themobile device app 104, and the inhaler 106.

Information 108 is downloaded from the cloud 102 by the app 104 via WIFIand/or mobile network connectivity. In this particular example, theinformation 108 includes a prescription 110, a dosage schedule 112, aquestionnaires 114, firmware updates 116, dispensary details 118,recalls 120 and physician appointment and booking details 122. Theinformation 108 may be updated on the cloud 102 and downloaded inreal-time to the app 104 so long as WIFI and/or mobile networkconnectivity between the app 104 and the cloud 102 is maintained.

In addition, information 124 is typically downloaded from the app 104 tothe inhaler 106 via a Bluetooth link. The information 124 includes aprescription 110 and a dosage schedule 112, which may be updated on theapp 104 and downloaded in real-time to the inhaler 106 so long asBluetooth connectivity is maintained between the app 104 and the inhaler106. If Bluetooth connectivity is lost between the inhaler 106 and theapp 104, the information 124 is stored on the inhaler until it isupdated via download from the app 104 when Bluetooth connectivity isreestablished. This allows the inhaler 106 to continue to operateaccording to the dosage schedule 112 while connectivity is lost, andthen push notifications to the app 104 when connectivity isreestablished between the inhaler 106 and app 104.

FIG. 11 illustrates a flow chart showing a method 200 for downloadinginformation from the cloud to the mobile app and from the mobile app tothe inhaler. As shown in FIG. 10, for example, the information 108 isdownloaded from the cloud 102 to the app 104, and the information 124 isdownloaded from the app 104 to the inhaler 106, in accordance with thisparticular embodiment. In step 202, the information 108 is downloadedfrom the cloud 102 to the mobile device app 104 over WIFI or mobilenetworks. Based on the information downloaded in step 202, step 202 maybe followed by step 204, in which the app 104 may push notificationsonto the mobile device (represented by the mobile device 12 shown inFIG. 1). For example, the information 108 may include a dosing schedule112 shown in FIG. 10, and the notifications pushed onto the mobiledevice 12 may include visual, audible, and tactile notificationsindicating that it is time for a dose to be administered through theinhaler in accordance with the dosing schedule. For example, the app 104may cause the user's mobile device to vibrate, chime, and display acalendar notification when it is time to take a dose in accordance withthe dosage schedule.

Step 202 is followed by step 206, in which the app 104 causes the user'smobile device to scan for Bluetooth devices in the vicinity of themobile device. If the inhaler is within range of the mobile device, step206 is followed by step 208, in which the mobile device compares theuser's credentials stored by the app 104 against the credentials storedon the inhaler 106 to ensure that the mobile device is paired to thecorrect inhaler. This is a security measure requiring the particularinhaler to be registered to a particular mobile app installed on aparticular mobile device, with this step ensuring that only the specificinhaler registered to operate with the specific mobile device can bepaired the particular inhaler. For example, the user's inhaler 106 isregistered to pair only the user's mobile device, as controlled by themobile app 104 installed on the user's mobile device, when the inhaleris initially issued (and possibly prescribed by a physician) for use bythat particular user. This may include receiving a passcode orbio-identifier (e.g., fingerprint, retina scan, face photo, face scan,voice command) associated with the user. Step 208 is followed by step210, in which mobile device app 104 determines whether the user'sinhaler 106 is successfully paired with the user's mobile device runningthe mobile device app 104. If the inhaler is not successfully pairedwith the mobile device, the “no” branch is followed back from step 210to step 206, in which the mobile device continues to scan for Bluetoothdevices in the vicinity of the mobile device. If the inhaler issuccessfully paired with the mobile device, the “yes” branch is followedfrom step 210 to step 212, in which information (such as information 124in FIG. 10) is downloaded from the app 104 to the inhaler 106. Step 212is followed by step 214, in which the inhaler 106 may push notificationsonto the inhaler 106 based on the information downloaded in step 212.For example, if the information downloaded to the inhaler in step 212includes a dosage schedule (such as dosage schedule 112 in FIG. 10), thenotification pushed on the inhaler in step 214 may include displaying anotification on the inhaler. For example, inhaler 106 may activatenotification devices (e.g., a flashing LED, tactile vibration, audiblebeep alarm, audible voice alarm, etc.) on the inhaler when it is time totake a dose.

Step 214 is followed by step 216, in which the app 104 routinely checkswhether the user's inhaler 106 is still paired to the user's mobiledevice. If the inhaler is no longer paired with the mobile device, the“no” branch is followed back from step 216 to step 206, in which themobile device scans for Bluetooth devices in the vicinity of the mobiledevice. If the inhaler remains paired with the mobile device, step 216is followed by step 218, in which the app 104 checks the cloud 102 forupdates to be downloaded (for example, updates to the information 108shown in FIG. 10); and the inhaler 106 checks the app 104 for updates tobe downloaded (for example, updates to the information 124 shown in FIG.10) If updates are available, the “yes” branch is followed from step 220to step 212, in which the updated are downloaded from the cloud 102 tothe app 104 and/or from the app 104 to the inhaler 106. If there are noupdates available, the “no” branch is followed from step 220 to step214, in which the inhaler 106 continues to push notification inaccordance with the dosage schedule. The type and frequency of thenotification activated by the inhaler 106 and the app 104 may typicallybe controlled by the user through setting available in the app 104.

Referring again to FIG. 10, the inhaler 106 also acquires canisterinformation 126 when a canister 150 containing medication is installedin the inhaler 106. The canister information 126 may be stored in acomputer-readable format (represented by the cartridge memory 28 shownin FIG. 2B) that is physically located on the canister 150 or on themouthpiece holding the canister. For example, the canister information126 may be stored on an electronic tag located on the canister, such asa barcode, QR code, RFID tag, NFC chip or another suitable type ofcomputer readable device or indicia. Additionally or alternatively,canister information 126 may be stored on an electronic tag located onthe mouthpiece unit, which is typically attached to the mouthpiece unitwhen the canister is installed into the mouthpiece unit, for example atthe formulator or dispensary. As another alternative, the canisterinformation 126 may be stored in an electronic chip carried by thecanister or the mouthpiece unit. As another option, a code (e.g.,canister serial number) may be stored on the canister or mouthpiece,which the app 104 uploads and uses to look up (index) information storedby the app or in the cloud. For example, the app 104 may use the codestored with the canister to download a portion of the canisterinformation from the formulator's website (e.g., chemical contents ofthe canister, packaging date, expiration date) and from a physician'swebsite (e.g., dosing schedule). In this particular example, thecanister information 126 is encoded as a barcode on the canister 150 orthe mouthpiece unit. The inhaler 106 includes a canister memory reader(represented by the cartridge memory reader 29 shown in FIG. 2B). Inthis example, the canister memory reader is a barcode reader thatdecodes the barcode on the canister 150 to obtain the canisterinformation 126. In this particular embodiment, the canister information126 includes a medication (or other contents) quantity and description128, and a batch number 130. The inhaler updates the canisterinformation along with dose utilization information as the canister isused, such as doses delivered 132, doses remaining 134, logging of theengagement and disengagement of the canister 136, and a lock status 138.

In this particular embodiment, the inhaler 106 compares the prescription110 (downloaded from the cloud, for example from the prescribingphysician's website) to the medication description 128 carried on thecanister or mouthpiece, which may be issued separately from the inhalerpump unit (for example by a dispensary) to determine if there is amatch. If the prescription 110 matches the medication 128 in thecanister, the lock 138 is disengaged allowing the inhaler to dispenseaccording to the dosage schedule 112. If the prescription 110 does notmatch the medication 128, the lock 138 is engaged to prevent the inhaler106 from dispensing.

Following the delivery of a dose, the inhaler updates the canisterinformation 126 including the doses delivered 132 and doses remaining134. The updated canister information 126 is uploaded from the inhaler106 to the app 104 via Bluetooth connectivity. The upload from theinhaler 106 to the app 104 occurs in real-time if Bluetooth connectivityis available between the user's inhaler and the user's mobile device.Alternatively, if Bluetooth connectivity is not available at the time ofdose administration, the canister information 126 is uploaded at a latertime when Bluetooth connectivity reestablished. This allows the inhaler106 to push notifications to the app 104, such as doses remaining 134,when connectivity between is reestablished between the inhaler 106 andapp 104. The app 104 then uploads information 140 (including the updatedcanister information 126 received from the inhaler 106) to the cloud 102via WIFI and/or mobile network connectivity. This information 140 mayalso include answers to questionnaires 142 (such as post-dosagefeedback), purchases 144, and ancillary device information 146. Again,the app 104 uploads the updates to the cloud 102 in real-time ifcommunication connectivity is available between the user's mobile deviceand the cloud. Alternatively, if connectivity is not available when theapp receives an update from the inhaler, the canister information 126 isuploaded at a later time when communication connectivity reestablished.It should be noted that additional post-dose feedback may be receivedfrom the user and uploaded to the cloud at one or more specified timesafter dose administration, such one hour later, at the time of expectedmedication onset, at bed time or in the morning. This additionalreporting provides a safety mechanism for fraud detection as well as aricher information set for assessing the effectiveness and side effectsof the product administered by the inhaler on a per-dose basis. Thishigher level of user feedback may be particularly advantageous when theinhaler is used for controlled substances, clinical trials, addictiontreatment, judicial supervision, cases of prior inhaler misuse, acutecare, higher-risk settings (e.g., foster care, hospice) and othersituations that justify heightened reporting requirements.

FIG. 12 is a flow chart showing a method 300 for uploading informationfrom an inhaler to a mobile device app, and from the mobile app to thecloud, in accordance with an embodiment. In step 302, the inhaler pumpunit acquires information (such as canister information 126 fromcanister 150 in FIG. 10) from the cartridge, for example by reading anelectronic tag or chip carrier on the canister or the mouthpiececarrying the canister. The cartridge information is typically acquiredwhen the cartridge is installed into the pump unit and is updatedwhenever the canister is used. The pump unit also uploads the canisterinformation to the mobile app running on the mobile device registered towork with the inhaler and a series of checks. For example, step 302 isfollowed by step 304, in which the mobile app compares the medicationdescription 128 acquired from the canister to the prescription 110downloaded from the cloud for the user registered to use the inhaler. Ifthe medication description does not match the prescription, the “no”branch is followed from step 302 to step 310, in which the mobile app104 instructs the inhaler 106 to lock the inhaler, and the inhaler doesso for example by moving an abutment to physically block depression ofthe dispensing button. Step 310 is followed by step 312, in which theapp and inhaler activate associated alarms and notifications. Forexample, the inhaler and the mobile app may also display or play one ormore “lock-out” notifications, such as a blaring alarm. The app may alsosend a communication to one or more designated third parties, such asthe user's physician, parent, care taker or authorities to report anapparent attempt to misuse the inhaler. Additional steps may be requiredto reactivate the inhaler and distinguish between an accidental mix-upand fraudulent attempt to misuse the inhaler.

If the prescription matches the medication contents, the “yes” branch isfollowed from step 304 to step 306, in which the app checks for aproduct recall, prescription change, authorization change or otherfactor indicating that inhaler should not be used to administer theproduct in the canister. This may include checking or downloadinginformation from multiple cloud locations, such as websites associatedwith the formulator, provider, clinical trial monitor, guardian,facility (e.g., hospice) manager, caseworker, parole officer, judicialsupervisor, offender database, and so forth. If there is a productrecall or other information indicating that the contents of the canistershould not be administered, the “yes” branch is followed from step 306to step 310, in which the app places the inhaler in a locked-out statefor the applicable cartridge, typically by blocking the dispensingbutton. If there is no product recall or other information indicatingthat the contents of the canister should not be administered, the “no”branch is followed from step 306 to step 308, in which the mobile appdetermines whether the authorized doses (or dosage) have been reached orexceeded, typically by checking the prescription against the updatedcanister information reflecting prior dose administration from thecanister. If the authorized doses (or dosage) have been reached, the“yes” branch is followed from step 306 to step 310, in which the appplaces the inhaler in a locked-out condition for the applicablecartridge, typically by blocking the dispensing button. If theauthorized doses (or dosage) have not been reached, the “no” branch isfollowed from step 308 to step 314, in which the inhaler and the mobileapp activate notifications to alert the user that a dosing window isopen (dose scheduled). The inhaler then allows the dispensing button onthe inhaler to be depressed only enough times (and may also restrict thedepth of depression of the button) to allow the user to take thescheduled quantity.

Following administration of the scheduled dose, step 314 is followed bystep 316, in which the inhaler updates the canister information toreflect this dose, which is uploaded to the app. The upload occurs inreal-time if there is connectivity between the inhaler and the app.Alternatively, if there is no connectivity at the time of doseadministration, the upload occurs when connectivity is reestablished.Similarly, the app may upload information reflecting dose administrationto the cloud, where it is received and reviewed by authorized personnelor systems. In this particular embodiment, step 316 may be followed bystep 318, in which the inhaler scans for Bluetooth devices. If a mobiledevice is located within pairing range, step 318 is followed by step320, in which the inhaler pairs with the mobile device and checks thecredentials of the inhaler against the credentials to ensure that theuser's inhaler only pairs with user's mobile device, which it isregistered to work with. This may include receiving a passcode orbio-identifier (e.g., fingerprint, retina scan) associated with the userand other security checks. If the credentials and other security checksare confirmed, step 320 is followed by step 322, in which the inhalerdetermines whether it is paired with the user's mobile device. If theinhaler is not paired with the user's mobile device, the “no” branch isfollowed back to step 318, in which the inhaler scans for Bluetoothdevices, which may include attempting to pair with another mobile devicewithin pairing range. If the inhaler is not paired with the user'smobile device, the “yes” branch is followed to step 324, in which theinhaler canister information update is uploaded from the inhaler to themobile app. The inhaler canister information update may also be uploadedfrom the mobile app to the cloud. Step 324 is followed by step 326, inwhich the user's mobile device (as controlled by the mobile app) and theinhaler activate notifications indicating that the scheduled dose hasbeen taken and recorded.

FIG. 13 is a logic flow diagram illustrating a procedure 400 integratingthe smart inhaler with the mobile app and components of the cloud. Thefollowing description will also make reference to the smart inhalersystem 10 shown in FIG. 1. While the procedure is applicable to clinicaltrial participants and other users of the smart inhaler, this particularexample will refer to a patient (user) and provider (physician). In step401, the patient registers on the patient roster on the provider system15 a, which the provider accepts. Step 401 is followed by step 402, inwhich provider recommends or prescribes a treatment or medication forthe patient, which the patient accepts. Step 402 is followed by step403, in which the provider issues the prescription 15 b typically byordering a cartridge with a pressurized canister containing theprescribed medication from the formulator 18 for delivery to adispensary 15 c selected by the user. The provider system 15 a alsonotifies the dispensary 15 c to expect and prepare for the delivery.Step 403 is followed by step 404, in which the formulator 18manufactures the prescribed cartridge 11 b by loading a canister withthe prescribed medication, installing the canister into a mouthpieceunit (engaging the single-use clasp in the mouthpiece unit), and sendingthe cartridge 11 b to the dispensary 15 c. Step 404 is followed by step405, in which the patient receives the cartridge 11 b from thedispensary 15 c and installs the cartridge into the pump unit 11 a.

To activate the smart inhaler 11, step 405 is followed by step 406, inwhich the patient pairs the microprocessor 11 c in the pump unit 11 awith the smart inhaler mobile app 12 running on the user's mobiledevice, typically a smartphone. (See FIG. 11). Step 406 is followed bystep 407, in which the mobile app 12 establishes communications with theprovider system 15 a. Step 407 is followed by step 408, in which theprovider 15 a sends a dosing schedule for the cartridge 11 b to thepatient, for example through a communication between the provider'smobile app 16 and the patient's mobile app 12. In the particularembodiment, for example, the Provider inputs the dosing schedule intothe dashboard or network portal of the provider system 15 a, whichdownloads the dosing schedule to the Provider's mobile app 16. Theuser's mobile app 12 then downloads the dosing schedule from Provider'smobile app 16 over the cloud 17. The user's mobile app 12 then downloadsthe dosing schedule to the memory 11 d of the smart inhaler 11. Step 408is followed by step 409, in which the patient enters pre-doseidentification information into the patient's mobile app 12, or in somecases into the smart inhaler 11 directly (See FIG. 9). Step 409 isfollowed by step 410, in which the smart inhaler 11 unlocks for theauthorized dosing event, typically for a specified number of puffs(pumps of the dispensing button).

After the user takes the authorized dose, the inhaler 11 automaticallylocks and step 410 is followed by step 411, in which the inhaler 11uploads a dose confirmation to the patient's mobile app 12, whichuploads the dose confirmation to the provider's mobile app 16, which mayfurther upload the dose confirmation to the formulator 18. Step 411 isfollowed by step 412, in which the formulator 18 or the provider 15 a,typically through the mobile app 16, may send a post-dose notificationto the patient's mobile app 12. Step 412 is followed by step 413, inwhich the user enters identification information, which is validated bythe mobile app 12 (see FIG. 9). Step 413 is followed by step 414, inwhich the user enters post-dose feedback (see FIGS. 14-17). Step 414 isfollowed by step 415, in which the inhaler 11 may enter a locked-outstate if the required post-dose feedback is not received, or if analysisof the post-dose feedback indicated that the inhaler has been used (ormay have been used) fraudulently or improperly (see FIG. 9).

The smart inhaler system 10 can also be used to order and fill newprescriptions and refill prescription. This is represented by step 416,in which the provider mobile app 16 sends a new prescription or refillnotification to the patient's mobile app 12. Step 416 is followed bystep 417, in which the patient accepts the prescription, which iscommunicated through a refill acceptance notice sent from the patient'smobile app 12 to the provider's mobile app 16. This may be accompaniedby a “stop-use order” for the previous cartridge 11 b if there are dosesremaining that should not be taken by the patient (see FIG. 7). Routine400 then loops back to step 403, in which the prescription is ordered,filled and picked up by the patient.

FIG. 14 is a conceptual illustration of a user interface 1400 displayedby the mobile app showing a dosing schedule. The dosing schedule showsthe associated product, in this example “Alprazolam,” the date and timeof the scheduled dosing events, the quantity to be administered, and thedoses remaining after the dosing event. In this example, the quantity “2puffs” instructs the user to press the dispensing button twice for eachdosing event, after which the dispensing button is automatically locked.An associated “doses taken” schedule can also be displayed to show thedoses previously taken by the user. In multi-cartridge and multi-userembodiments, the dosing schedules are made available on a per-cartridgeand per-user basis. The dosing schedule 1400 also displays a “settings”icon that the user (or other authorized person) can select to initiate avariety of menu-driven configuration panels. The configurable featuresof the system, which can typically be set on a per-cartridge andper-user basis, include items such as the elements required for useridentification (e.g., password, MMJ Registration Card number, facephoto, fingerprint, etc.), post-dose feedback, internal alarm protocolsperformed by the smart inhaler, external alarm protocols performed bythe smart inhaler, network addresses of associated cloud platforms, andso forth.

FIG. 15 and FIG. 16 are conceptual illustrations of two user interfaces1500 and 1600 displayed by the mobile app for receiving post-dose userfeedback. These user interfaces show two representative questions of aradio-button questionnaire that the user may be required to complete.User interface 1500 allows the user to answer “yes” or “no” to thequestion “Did you experience any abdominal pain during the night?” Userinterface 1600 allows the user to select a radio button indicating theduration of the pain. In general, the questionnaires can be supplied ona per-cartridge basis and may be part of the canister information storedin the cartridge memory supplied with each cartridge. The questionnairemay also be updated or modified over the cloud based on the needs ofindividual users (e.g., children, elderly patients, patients withprogressive conditions, etc.) and protocols (e.g., clinical trialadministration, experimental medication or other product evaluation,etc.).

FIG. 17 is a conceptual illustration of a user interface 1700 displayedby the mobile app for receiving multi-media and interactive userfeedback. This user interface 1700 shows a third question of thequestionnaire using a slider to indicate a level of pain experiencedalong with a text box 1701 allowing the user to enter a textual responseto the question “Describe in your own words how you are feeling, anyrecent changes, and how well you believe the treatment is working.” Theuser interface 1700 also displays a number of icons 1702 a-1702 n thatthe user can select to enter various types of multi-media andinteractive feedback. For example, the icon 1702 a may be selected toallow the user to attach a picture taken with the camera on the user'smobile device, the icon 1702 b may be selected to allow the user toattach a video taken with the camera and microphone on the user's mobiledevice, the icon 1702 c may be selected to allow the user to attach afile, the icon 1702 n may be selected to allow the user to initiate achat or video chat session, and so forth. These features areparticularly helpful for conversing with the user's physician orclinical trial administrator. For example, a picture of a skin rash orwound, a video of the user experiencing sleep apnea, or photo of theuser's face for security identification can be attached and uploaded forreview by the user's physician, clinical trial administrator, theformulator of the product in the subject cartridge, or an artificialintelligence platform. The user's vital signs and other measurementstaken by ancillary devices can also be uploaded from the user's mobileapp for review along with other clinical test results obtained fromthird-parties (e.g., lab tests, MRI results, etc.). The user can theninitiate a text or video chat session to discuss these multi-mediamaterials with the user's physician or clinical trial administrator. Thesystem 10 consolidates all of the relevant information in an singleplatform to facilitate the conversation. Based on all of these materialsand interactive patient interviews, the physician or clinical trialadministrator can take appropriate actions, such as changing the dosingschedule, ordering a new cartridge, or entering a “stop-use order” forthe relevant cartridge, which are automatically downloaded to the user'smobile app and on to the user's smart inhaler.

It will therefore be appreciated that the illustrative embodiments shownin the figures include an electronic metered-dose smart inhaler, mobileapp, and cloud-based software system that validates users and inhaleruse protocols (e.g., medical prescriptions, clinical trial regimens,experimental drug regimens), controls and monitors per-dose usage,captures efficacy results and feedback from medical cannabis (marijuana)patients for review and input by prescribing physicians, medicineformulators and artificial intelligence. Conventional cannabis deliverymethods fail to provide the ability for patient, physician andformulator interaction using per-dose administration and feedback data.This communication loop is critical to ensure that physicianrecommendations and specific prescribed formulations are beneficial tothe treatment of the patients ailment. Medicine effectiveness data andpatient symptom feedback is severely delayed to the physician and to theformulator. Patient feedback needs to occur in real-time so that atreatment regime can be adjusted to meet patient needs as quickly aspossible between doctor's office visits which typically take place every90 days.

Protocol administrators, such as physicians and clinical trialoperators, using conventional cannabis medicine administration andmonitoring systems are unable to make critical early adjustments topatient's regimen due to the time lag in understanding the initial andearly effects on the patient. Conventional cannabis systems also fail toprovide physicians with a reference database to assist decisions theymake on recommending the most effective medicine produced by the bestformulator to their patients. Formulators can also benefit fromunderstanding how their medicines are affecting patient ailments andwhether formulation adjustments need to be made to specific medicines toincrease the efficacy for targeted ailments. Currently there are noexisting device systems that allow formulators to gather useful datafrom patients that help guide in adjusting their medicines to increasethe benefits of their medicine product offering.

The smart inhaler system provides systems and methods for collecting andorganizing per-dose, typically real-time user feedback that isaccessible to physicians, formulators, artificial intelligence, andother research and analysis systems and practitioners The smart inhalerand associated mobile app gather patient (and other user) inhaler usedata and allows for user input regarding effectiveness of a protocoladministered by the smart inhaler, such as a treatment regime forclinical trial or prescribed medication. This information is gatheredand stored on a centralized network server where physicians,formulators, researchers and other practitioners can analyze the data tobetter understand if and when adjustments in protocol or formulation arenecessary. The smart inhaler system thus creates a critical loop ofcommunication to improve treatment efficacy by eliminating any delay ofinformation provided by the patient.

The smart inhaler system incorporates multiple sources and methods inthe gathering of relevant data and perform analytics regarding thepatient's inhaler use, physical status and medical condition. The systemincorporates vitals gathered from ancillary and add-on components thatcapture data, such as but not limited to, patient heart rate, bloodpressure, body temperature, respiration rate, glucose monitoring, bloodoxygen level, sleep patterns, exercise/activity patterns and weightmonitoring. The device system will incorporate all forms of data,feedback and information into the patient's account folder on the systemnetwork for review by the physician and formulator. The device systemsoftware will also incorporate artificial intelligence (Al) that willanalyze and process the patient data in order to provide predictivemodeling and make recommendations in regards to potential patienttreatment regimes, adjustments in dosing and formulations to increaseefficacy and increase assurance in Physicians and Formulators that theproper treatment is being provided to the patient. Physicians may alsoupload patient clinical test data to the device system to increase theaccuracy of the Al analytics. This clinical test data may include but isnot limited to, blood test data, cardiovascular test data, MRI/CAT scantest data, and genome test data.

Physicians may use the Al results and per-dose, typically real-time datacollected by the smart inhaler system to make instant modifications tothe patient's dispensing amount and the frequency of the dispensing toimprove treatment outcomes. The access to real-time data also allows thephysician to monitor the dispensing device use and confirm if thepatient is adhering to the prescribed regimen. The centralizedinformation database created by the smart inhaler system will allowphysicians to access patient and Al input and determine whichformulators are producing the medicines with the highest efficacy ratesand allow physicians to make a recommendation based on accurate datainstead of making a random decision in selecting a medicine. Providingreal-time patient feedback that is accessible to the formulators andincorporating Al results is invaluable in ensuring their medicines arecompounded to target specific ailments. This user feedback and Al dataallows the formulator to determine adjustments that are required toeliminate unwanted side effects of a medicine. There are no currentmethods or database resources for formulators to understand how theirmedicines are benefiting or negatively affecting users. The smartinhaler system will allow formulators to analyze user data, incorporateAl recommendations and make necessary changes to optimize and improvetheir medicines. The device in combination with the network softwarewill allow formulators and physicians a very quick and efficient productrecall capability in the event that a medicine needs to be recalled. Theformulator can issue an electronic recall notice that will lock-outfurther use of the device utilizing the medicine to be recalled.Detailed electronic messaging can be sent to patients and doctorsnotifying them of the recall event.

The smart inhaler is a battery powered hand-held device that is slightlylarger than a traditional inhaler product. It is familiar in appearanceto a traditional inhaler with regards to the mouthpiece where themedicine is dispensed. The smart inhaler has a reusable main upperhousing that provides an enclosure for the electronic components. Thelarger size is directly related to the space required for housing thedevice electronics and power supply. The device has as an internal PCBwith a microprocessor, Bluetooth chip set, NFC antenna and/or RFIDreader, battery charging circuitry, rechargeable battery, LED statusindicators and other surface mounted components for completing theelectronic system design. The device will connect to a smartphone and/ortablet to communicate with the software application. The device willincorporate electronic features and functions such as but not limitedto; detection of dispensing events, preprogrammed dispensing eventtimes, data log of dispensing events, alerts and notifications ofdispensing events, visual/tactile/audible device status indicators, lowpower consumption/sleep mode and an accelerometer. The device may or maynot have a power “On/Off” switch and may or may not always remain in astate of “On, Standby or Sleep mode”. The software also has thecapability to gather and aggregate information from third party smartdevices such as Fitbit®, Apple Watch®, Garmin® watches and other smartinformation gathering devices. The information gives additional channelsof information to the physician such as heart rate, sleep patterns,activity levels that can be combined with the patient's real-timefeedback to develop a holistic understanding of how the treatment planis working for the patient.

The smart inhaler has a removable and disposable lower housing thatincorporates the valve stem, valve and jet features for properlydispensing the MDI canister medicine, a mouthpiece where the medicineexits the housing and a mating feature to secure the MDI canister intothe lower housing. In traditional inhalers, the MDI canister is insertedfrom the top of the actuator. The smart inhaler differs in this and theMDI canister is attached to the lower housing and the assembly isinserted into the bottom of the device. The lower housing is removableand replaceable to the upper housing by means of a snap-fit feature.This feature engages with the pump unit (also called the “upperhousing”) by aligning and pressing the lower housing (also referred toas the or “mouthpiece unit” or “cartridge” when the mouthpiece unit iscarrying a canister) into position. The lower housing may be disengagedand removed by pressing side tabs to release the snap-fit allowing thetwo parts to separate and pull apart the housings. The lower housing ofthe smart inhaler also has a feature that secures the MDI canister intothe housing by means of a permanent snap fit. This feature allows thecanister to be pressed into the lower housing for dispensing until thecanister contents are depleted. The empty canister and lower housing areboth discarded and a new canister/lower housing assembly can beinstalled into the upper housing. When the canister has been permanentlysecured into the lower housing and subsequently and forcefully removedfrom the lower housing, the permanent snap feature that secures thecanister will be deformed and/or destroyed to the extent that thecanister cannot be installed into the lower housing to be reused. Thisfeature is to ensure that the lower housing is discarded after thecanister contents are depleted for sanitary purposes and also to preventother manufacturer's canisters from being inserted into the lowerhousing and reused ion the smart inhaler. The lower housing assembly isequipped with on-board memory storage that is capable of storing andcontaining information such as, but not limited to, canister contents,contents manufacturer, manufactured date, lot number, batch number,expiration date, etc. The memory component may be incorporated into thelower housing, lower housing assembly or the MDI canister. When thelower housing assembly is inserted into the upper housing, the upperhousing PCB is equipped with a component to wirelessly read the datastored on the lower housing. The upper housing detects the installationof the lower housing, collects the information from the lower assemblyand ports this data wirelessly to the smartphone app. The informationcan be viewed by the user on the smartphone app and viewed by thephysician and formulator on the central network. Each time the lowerhousing is removed or inserted, the device will log this event. If alower assembly with medicine “A” is inserted and dispensing eventsoccur, the device will record and store these events to trackconsumption for that specific medicine. When medicine “A” is reinsertedthe device will resume counting dispensing events for Medicine “A” andcontinue counting until the canister is depleted. As the lower housingassembly with Medicine “A” approaches depletion, approximately 100dispensing events, the device will send a notification to the smartphoneapp and alert the patient and/or physician that the MDI canister isalmost empty. This advance notification allows the patient to ensurethey have an immediate refill on-hand to replace the depleted canisteror allows them the time to contact the physician for a prescriptionrefill if required. The device app and software can automatically notifythe prescribing physician that the patient's prescription is almostempty. The patient can then directly request a prescription refill byusing the smartphone app. This system feature avoids patients fromhaving to spend the extra money for an office visit with their doctorand also avoids the time required for this visit. In turn, the physiciancan review the patients adherence and feedback using the online systemnetwork to ensure the patient is progressing satisfactorily prior toauthorizing the prescription refill. Once approved by the physician, theprescription is automatically send to the patient's dispensary and amessage is sent to the patient when the prescription is ready for pickup. The physician can also reject the refill request and instruct thepatient to schedule an in office visit for an evaluation.

The reusable upper housing of the device has a integrated dispensingbutton that interfaces with the canister when the lower assembly isinstalled. With traditional inhalers, the patient presses down on theactual canister to dispense, whereas in the smart inhaler, the user willpress down on the dispensing button that forces the canister down inorder to dispense. The upper housing has an internal function that canbe controlled to allow the button to be pressed down or prevent thebutton from being pressed down to avoid accidental or unauthorizeddispensing. A mechanical feature will engage with the dispensing buttonto create an interference of the up and down movement of the button andessentially positioning the button in a state of non-function. Thisfunction is controlled electronically via commands sent from the systemapplication installed on a smartphone. The device and/or app can beprogrammed for individual dispensing events. When the dispensing eventapproaches, the button engagement feature will disengage allowing theuser to dispense a pre-set amount. When the dispensing is completed thebutton engagement feature will re-engage the button to preventdispensing. There may be a preprogrammed window of time allowing thepatient to dispense the medicine at their convenience. For example, thetime to dispense is set for 3:00 PM, the device would disengage thedispensing button at 2:30 PM and remain disengaged until 3:30 PM,allowing the patient to take their medicine anytime within the 1 hourwindow. At 3:31 the dispensing button would be re-engaged to prevent thedispensing event until the next programmed event. The device app may ormay not allow the user to override the dispensing button engagement byentering a passcode to disengage the button during times other that thepreprogrammed dispensing events. For example, the patient realizes at3:45 PM that the pre-programmed dispensing event was overlooked, apassword code can be entered to immediately disengage the dispensingbutton for a short period, approximately 1-3 minutes, allowing thepatient to take the previously overlook dispensing event. When apre-programmed dispensing event is approaching, a notification will beactivated. This notification may be in the form of an audible, visualand/or tactile (vibration) alert. The notification may also be in theform of an email, text or in-app alert on the users smartphone. Thisnotification may be a combination of any of the above mentioned methods.When the dispensing event time window has been initiated, the dispensingbutton is disengaged and a countdown clock begins and is displayed onthe smartphone app. This allows the patient to see how much time isremaining prior to the re-engagement of the dispensing button. Thisfeature has been created to assist parents and caregivers to bothmonitor and ensure children do not exceed dosing quantities and helpsreinforce the treatment regimen. There may be an app feature allowingthe patient to extend the dispensing time window or reschedule thedispensing event to a time that is more convenient. The same mechanicalfeature that engages the dispensing button, can also engage the lowerhousing assembly to prevent removal. The lower housing may have afeature that extends up into the main housing when installed. Thisextended detail, or tab, allows the mechanical feature to engage the taband prevent the lower assembly from being removed from the main housing.When the canister contents are depleted, the smart inhaler willdisengage the tab and allow the user to remove the lower assembly.

During the examination of a patient, a physician determines that MMJ isa suitable alternative to addressing the patients ailments caused byCrohn's disease. The physician recommends the smart inhaler as themethod of delivery for the MMJ. The physician logs into the onlinesystem network to access his assigned dashboard. The physician canbrowse various categories of information. One category may be “PatientAilments”, where numerous ailments are listed, such as but not limitedto: ADHD, Alzheimer's, Arthritis, Cancer, Crohn's Disease, etc. Thephysician selects “Crohn's Disease” and a page of medicines specificallyformulated for Crohn's is displayed. With each individual formulationlisted, detailed information may be displayed such as but not limitedto: Manufacturer/Formulator of Record, formulation contents, percentagesand types of cannabinoids and THC, last date of formulation revision,ect. . . . Also displayed with each individual formulation is patientgroup feedback for that specific formulator's medicine. This data may beused by the physician is guiding his decision on which formulation torecommend. The group sourced feedback may provide information onformulation effectiveness, side effects, dispensing levels anddispensing frequency, likes/dislikes, etc. Patients may also have theability to rate formulations on a scale of 1 to 5 to assist inestablishing a method for “scoring” how successful formulators are ataddressing ailments with their medicines. This scoring will allowphysicians to quickly see which formulator is focused on providing thebest results with their specific medicines. For example, the physicianhas 6 formulator's to select from with regards to medication for Crohn'sdisease. 4 of the six formulator's have a rating of less than 3 stars, 1has a 3.4 stars and the remaining 2 have scores above 4 stars. Thedoctor can select the 2 highest ranked formulators and do a side by sideproduct comparison, read patient feedback, and now make an educateddecision on which formulator's medicine is best for his patient'sspecific ailment. The physician selects “Formulator #6” and a list oflocal dispensaries carrying that specific medicine is displayed allowingthe physician to select a dispensary that is convenient for the patient.Next, a window may be displayed for the physician to enter therecommended dispensing regime for his patient. Information such as butnot limited to, medicine dispensing amounts, dispensing frequency,treatment duration, approved refills, etc. will be entered and storedinto the on-line system. When the prescription is entered, a unique IDcode is generated and attached to an electronic prescription that isemailed to the patient or authorized guardian. The patient visits thedispensary and presents the e-prescription to be filled. The patientpurchases the dispensing device and the prescription.

In order to use the dispensing device, the patient is first required todownload and install the free smartphone application from Google Play®or the Apple Store® and the device's batteries must be fully charged.Once this is completed, the smartphone's Bluetooth wirelesscommunication interface must be turned on. Bluetooth will search anddetect the device and connect. The patient will open the deviceapplication and will be asked to complete some basic information, suchas but not limited to: name, address, age, weight, etc. The patient willalso be required to read and agree a “private information disclosure”that will allow for specific personal information to be gathered andsynthesized from a HIPPA compliant database on the system network.Additional syncing of third party device collection methods such asFitbit, Apple Watch etc. can be completed at this time. After this iscompleted, a “Device Manual and Patient Instruction” section will walkthe patient through the device features and functions, how to use thedevice, how to install the MDI cartridge, how to dispense the medicine,FAQ's, troubleshooting, etc. Next, the patient will install the MDIcanister. The app will instruct the user to place the MDI cartridge intothe bottom of the main housing and slide up until the canister assemblylocks into place. When the canister is being installed the device willdetect this action and via the smartphone, prompt the user to enter theunique ID code that was included with their electronic prescription.When the code is entered, the system software will download thetreatment regime recommended by the physician to the smartphone and thenwirelessly transfer and flash this information to the device's memory.For example, the physician's recommendation is for the patient todispense 6 mg or medicine every 4 hours. The device is now programmed tomonitor, track and notify the patient for content dispensing accordingto the physician's recommendation. Also, when the canister is installedthe device will wirelessly read the data stored on the canister assemblyregarding the formulator of record, contents, date manufactured, etc.This information is uploaded in real-time to the on-line system networkand is accessible by the physician and formulators. The device is readyfor use and may remain disengaged until the first dispensing event isrecorded. When the patient administers their first dispensing from a newcanister, the device's internal clock starts and will notify the patientwhen the next dispensing event is required in 4 hours. For patientreference, a daily dispensing schedule may be displayed on thesmartphone outlining the times throughout the day that a dispensingevent should occur. After the initial dispensing of the new canister iscomplete, the device will engage the dispensing button preventingadditional or accidental dispensing until the next scheduled dispensingevent. The device will go into a sleep mode until the next dispensingevent is approaching and at this time, the device will wake-up andvibrate and/or flash the LED indicator to notify the patient. Thesmartphone app can also simultaneously notify the patient through anaudible alarm, vibration and/or screen message. The app will allow thepatient to determine a window of time that the dispensing event canoccur. This time can be adjusted and set for 15 to 30 minutes before andafter the designated time. When a dispensing event is authorized and thetime to dispense is within the set window of time, the device willcontinually send periodic reminders to the patient that the dispensingevent needs to occur. A countdown timer may be displayed on thesmartphone with the remaining time before the dispensing event windowhas expired. If the patient is in an inconvenience location, for examplea client meeting at work, the patient may postpone the dispensing eventfor a future time prior to the next scheduled dispensing event. Duringan active dispensing event time window, the device's dispensing buttonwill stay engaged and the device's LED indicator will flash green untilthe patient shakes the device and canister 5 or more times to mix thecanister contents. The device's internal accelerometer detects thisaction and the LED indicator will change to a solid green and thedispensing button will disengage allowing the patient to press down thebutton and dispense the medicine. After the dispensing event hasoccurred the button is engaged and the device returns to a sleep mode.At any time between dispensing events, the patient can shake the deviceto force an exit from the sleep mode. After each dispensing event, theapp will prompt the patient to answer a set of questions relating to theeffects of the medicine. The patient will input their feedback and thisinformation will be uploaded to the on-line system network in real-timefor review by the physician and/or the formulator. This direct patientfeedback is beneficial to the physician to ensure the prescribed regimeis providing benefit to the patient and also allows the physician tomonitor any negative side effects experienced by the patient. Theformulator can also analyze the patient feedback to better understandthe efficacy of the medicine they produce. This patient feedback can beused by the formulator to make adjustments to specific medicinechemistry. For example, a high number of Crohn's disease patients may beusing a formulation to address their symptoms but 2 hours after adispensing event, the pain has returned, they are experiencingsleepiness by midday and their anxiety levels are increasing. Theformulator can then make necessary adjustments to address and/oreliminate these side effects and improve the effectiveness of thisspecific formulation for Crohn's patients. The device will track thetotal number of dispensing events for each individual canister. Forexample, a canister with a Crohn's disease formulation has incurred 60dispensing events and is removed from the device and a new, nighttimeformulation to help a patient sleep is inserted and incurs 2 dispensingevents. The next morning, the patient removes the nighttime formulationand reinserts the Crohn's formulation, the device will count the nextdispensing as event #61. The onboard memory located in the lowerassembly (mouthpiece and canister) allows the device to recognize andtrack each individual formulation that is inserted/removed from thedevice. When a canister's contents have been depleted, the app willnotify the user to remove the lower assembly and install a new canister.

An additional example of the device system in use could be for patientsuffering from PTSD. Shortly prior to the time of dispensing themedicine at a scheduled time, the device system will instruct thepatient to ensure their ancillary monitoring device, such as a FitBit,is on the patient's wrist. The system device may instruct and notify theuser to initiate a blood pressure check at a specific time, for example,5 minutes prior to the scheduled dosing time. The blood pressure devicemay be bluetooth enabled and the device system will automatically importthe test results or the user may manually enter the results into thesmartphone app of the smart inhaler system. The device system may alsoinstruct the user to connect an ancillary blood oxygen monitor to theirsmartphone and clip the monitor to their finger tip 2-3 minutes beforethe dosing event. All of the data is captured prior to the dosing eventand stored on the device system. The patient is then instructed todispense the medicine. At specific time intervals following the dosingevent, patient vitals and data will be monitored, automatically ormanually entered and recorded by the device system. For example, thepatient has a schedule doing event for 2:00 p.m., the device systemsends a notification alert at 1:50 p.m. for the user to ensure theirFitBit is charged and is on their wrist. The device system will instructthe user to sit, rest and refrain from any activity so that a restingheart rate can be obtained. Upon user confirmation, the device systembegins to record the user's heart rate via input from the FitBit. At1:55 p.m. the device system will instruct the user to take a bloodpressure reading. The blood pressure test is performed and the systemdevice will import the results from a Bluetooth enable blood pressuremonitor or the user can manually input the results into the devicesystem app, for example, 135/90 is typed and entered by the user intothe device system's smartphone app. The device system may then send anotification to the user at 1:59 p.m. to connect an ancillary bloodoxygen monitor an place the monitor's clip on the user's index finger.Now the device system has gathered and is continuously recording patientvitals prior to dosing. At 2:00 p.m. the device system notifies thepatient it is time to dose their medication as prescribed by thephysician. The patient dispenses the medication and the event isrecorded by the device system and the post-dosing monitoring softwareprogram is initiated. The system device will continue to record vitalsat specific time intervals. For example, the heart rate data is capturedand recorded every 30 seconds for minutes 1-5 after dosing and then thedevice system captures and records the heart rate every 60 seconds forminutes 6-15. The system device may then instruct the user to take andenter a second blood pressure reading at the 5 minute mark after dosingand again at the 15 minute post-dosing mark. The blood oxygen monitoringmay occur in a similar fashion as the heart rate monitoring and atspecific time intervals, the readings will be captured and recorded inthe device system. The post-dosing monitoring may only occur for thefirst 15 minutes after the dosing event or, depending on the patient'sneeds as determined by the physician, the post-dosing monitoring couldmay need to continue for the first 30 minutes after patient dosing andthen for 15 minutes every hour until the next scheduled dosing event.The device system now has multiple patient data points to compare,analyze and categorize. The post-dosing patient monitoring period andthe time in-between monitoring cycles is customizable according to thepatient's medical needs. The patient monitoring system intervals may beprovided in a device system default configuration, or be determined andadjusted by the physician, or automatically adjusted by Al analyzingpatient vitals history and making recommendations based on patienttreatment progress. Through the combination of using the smart inhaler,ancillary vital monitoring devices, capturing and recording patientvitals (pre and post-dosing) and using Al for predictive modeling,physicians and medicine formulators can make huge strides in improvingindividual treatment plans for patients and patient groups sufferingfrom similar ailments.

The present disclosure may be implemented using a smart metered-doseinhaler that operated in concert with apps running on one or more mobilecommunication devices (e.g., smartphones) one or more network-based orcloud-based platforms. Each of these devices includes a controllerutilizing a general purpose computing device, such as a microprocessorcontrolled by specialized computer software. As such, embodiments of thedisclosure may comprise adapting or reconfiguring presently existingequipment. Alternatively, original equipment may be provided embodyingthe disclosure.

All of the methods described in this disclosure may include storingnon-transient computer-executable instructions and associated results ina non-transient storage medium. These computer-executable instructionsand results may include any of the computer-implemented procedures orresults described in this disclosure and may be stored in any mannerknown in the art. The storage medium may include any storage mediumdescribed in this disclosure or any other suitable storage medium knownin the art. After the computer-executable instructions or results havebeen stored, they can be accessed in the storage medium and used by anyof the method or system embodiments described in this disclosure,formatted for display to a user, used by another software module,method, or system, etc. Furthermore, the results may be stored“permanently,” “semi-permanently,” temporarily, or for some period oftime. For example, the storage medium may be random access memory (RAM),and the results may not necessarily persist indefinitely in the storagemedium.

Those having skill in the art will appreciate that there are variousvehicles by which processes and/or systems and/or other technologiesdescribed in this disclosure can be effected (e.g., hardware, software,and/or firmware), and that the preferred vehicle will vary with thecontext in which the processes and/or systems and/or other technologiesare deployed. For example, if an implementer determines that speed andaccuracy are paramount, the implementer may opt for a mainly hardwareand/or firmware vehicle; alternatively, if flexibility is paramount, theimplementer may opt for a mainly software implementation; or, yet againalternatively, the implementer may opt for some combination of hardware,software, and/or firmware. Hence, there are several possible vehicles bywhich the processes and/or devices and/or other technologies describedin this disclosure may be effected, none of which is inherently superiorto the other in that any vehicle to be utilized is a choice dependentupon the context in which the vehicle will be deployed and the specificconcerns (e.g., speed, flexibility, or predictability) of theimplementer, any of which may vary. Those skilled in the art willrecognize that optical aspects of implementations will typically employoptically-oriented hardware, software, and or firmware.

Those skilled in the art will recognize that it is common within the artto describe devices and/or processes in the fashion set forth in thisdisclosure, and then use engineering practices to integrate suchdescribed devices and/or processes into data processing systems. Thatis, at least a portion of the devices and/or processes described can beintegrated into a data processing system via a reasonable amount ofexperimentation. Those having skill in the art will recognize that atypical data processing system generally comprises one or more of asystem unit housing, a video display device, a memory such as volatileand non-volatile memory, processors such as microprocessors and digitalsignal processors, computational entities such as operating systems,drivers, graphical user interfaces, and applications programs, one ormore interaction devices, such as a touch pad or screen, and/or controlsystems including feedback loops and control motors (e.g., feedback forsensing position and/or velocity; control motors for moving and/oradjusting components and/or quantities). A typical data processingsystem may be implemented utilizing any suitable commercially availablecomponents, such as those typically found in datacomputing/communication and/or network computing/communication systems.All of the technology described in this disclosure is suitable forimplementation using commercially available computing devices, such asmicroprocessors executing computer-executable software. These computingdevices may be interconnected via the Internet, mobile telephone voiceand data system, or other data suitable network.

This disclosure sometimes illustrates different components containedwithin, or connected with, different other components. It is to beunderstood that such depicted architectures are merely exemplary, andthat in fact many other architectures can be implemented which achievethe same functionality. In a conceptual sense, any arrangement ofcomponents to achieve the same functionality is effectively “associated”such that the desired functionality is achieved. Hence, any twocomponents may be combined to achieve a particular functionality can beseen as “associated with” each other such that the desired functionalityis achieved, irrespective of architectures or intermediate components.Likewise, any two components so associated can also be viewed as being“connected”, or “coupled”, to each other to achieve the desiredfunctionality, and any two components capable of being so associated canalso be viewed as being “functionally connected” to each other toachieve the desired functionality. Specific examples of functionalconnection include but are not limited to physical connections and/orphysically interacting components and/or wirelessly communicating and/orwirelessly interacting components and/or logically interacting and/orlogically interacting components.

While particular aspects of the present subject matter have been shownand described in detail, it will be apparent to those skilled in the artthat, based upon the teachings of this disclosure, changes andmodifications may be made without departing from the subject matterdescribed in this disclosure and its broader aspects and, therefore, theappended claims are to encompass within their scope all such changes andmodifications as are within the true spirit and scope of the subjectmatter described in this disclosure. Although particular embodiments ofthis disclosure have been illustrated, it is apparent that variousmodifications and embodiments of the disclosure may be made by thoseskilled in the art without departing from the scope and spirit of thedisclosure.

It is believed that the present disclosure and many of its attendantadvantages will be understood by the foregoing description, and it willbe apparent that various changes may be made in the form, constructionand arrangement of the components without departing from the disclosedsubject matter or without sacrificing all of its material advantages.The form described is merely explanatory, and it is the intention of thefollowing claims to encompass and include such changes. The disclosureis defined by the following claims, which should be construed toencompass one or more structures or function of one or more of theillustrative embodiments described above, equivalents and obviousvariations. it will therefore be appreciated that present inventionprovides significant improvements in electric power circuit reclosers.The foregoing relates only to the exemplary embodiments of the presentinvention, and that numerous changes may be made therein withoutdeparting from the spirit and scope of the invention as defined by thefollowing claims.

The invention claimed is:
 1. An electronic metered-dose inhaler systemincluding security features comprising a cartridge, a pump unit, and amobile app, wherein: the cartridge comprises: a canister containingpressurized contents for aerosol dispensing without burning orvaporizing the contents of the canister, a mouthpiece unit holding thecanister against a spring biasing the canister in a retraction directionallowing the canister to be reciprocated between the retractiondirection and an opposing insertion direction to dispense a portion ofthe contents of the canister through the mouthpiece unit each time thecanister is reciprocated, the pump unit comprises: a pump actuatorpositioned to reciprocate the canister to dispense the contents of thecanister through the mouthpiece unit when the cartridge is attached tothe pump unit in the operational configuration; a battery powering amicroprocessor, a memory, and a wireless radio; wherein the memory isoperative for storing the security information and associated securityprocedures; wherein the microprocessor is operative for unlocking thepump actuator to allow operation of the pump actuator in accordance withthe security procedures and security information, and for locking thepump actuator to prevent operation of the pump actuator that is not inaccordance with the security procedures and security information;wherein the mobile app is configured to run on a mobile deviceassociated with a user configured to pair and communicate with themicroprocessor of the pump unit, and wherein the mobile app isconfigured to communicate with other systems over a network and executecomputer instructions comprising: receiving pre-dose authorizationinformation from the pump unit, validate pre-dose authorization,unlocking inhaler for an a dose, entering the inhaler into a locked-outstate in response to determining that required post-dose feedback wasnot received or that received post-dose feedback raises a suspicion offraudulent or improper use.
 3. The electronic metered-dose inhalersystem of claim 1, further comprising activating an alarm displayed orplayed by the mobile device in association with entering the inhalerinto the locked-out state.
 4. The electronic metered-dose inhaler systemof claim 1, further comprising activating an alarm displayed or playedby the pump unit in association with entering the inhaler into thelocked-out state.
 5. The electronic metered-dose inhaler system of claim1, further comprising transmitting a notification from the mobile deviceto an cooperating system over the network in association with enteringthe inhaler into the locked-out state.
 6. The electronic metered-doseinhaler system of claim 5, wherein the cooperating system is associatedwith a prescriber of a medication in the canister.
 7. The electronicmetered-dose inhaler system of claim 5, wherein the cooperating systemis associated with a clinical trial administrator associated with asubstance in the canister.
 8. The electronic metered-dose inhaler systemof claim 5, wherein the cooperating system is associated with a lawenforcement agency.
 9. The electronic metered-dose inhaler system ofclaim 5, wherein the cooperating system is associated with a parent,guardian or care taker of an authorized used of a substance in thecanister.
 10. The electronic metered-dose inhaler system of claim 1,wherein the step of entering the inhaler into a locked-out statecomprises determining that required post-dose feedback was not received.11. The electronic metered-dose inhaler system of claim 1, wherein thestep of entering the inhaler into a locked-out state comprises:analyzing received post-dose feedback; and determining that thepost-dose feedback raises a suspicion of fraudulent or improper use ofthe inhaler.
 12. The electronic metered-dose inhaler system of claim 1,wherein the required post-dose feedback comprises feedback requiredduring a predefined time interval.
 13. The electronic metered-doseinhaler system of claim 1, wherein the required post-dose feedbackcomprises feedback required during a plurality of predefined timeintervals.
 14. The electronic metered-dose inhaler system of claim 1,wherein the required post-dose feedback comprises a bio-identifierentered into the mobile device.
 15. The electronic metered-dose inhalersystem of claim 1, wherein the required post-dose feedback comprises apassword entered into the mobile device.
 16. The electronic metered-doseinhaler system of claim 1, wherein the required post-dose feedbackcomprises a registration number entered into the mobile device.
 17. Theelectronic metered-dose inhaler system of claim 1, wherein the requiredpost-dose feedback comprises interactive feedback conducted with acooperating system over the network.
 18. The electronic metered-doseinhaler system of claim 1, wherein the required post-dose feedbackcomprises a photograph taken with the mobile device.
 19. The electronicmetered-dose inhaler system of claim 1, wherein the required post-dosefeedback comprises a user's assessment of efficacy of a substance in thecanister.
 20. The electronic metered-dose inhaler system of claim 1,wherein the required post-dose feedback comprises a user's assessment ofside effects caused by a substance in the canister.